INSUFFLATION NEEDLE, MODEL R65-933 |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE |
ALPHARETTA GA 30004 -338 |
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510(k) No: K000027
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510(k) Summary |
SE Decision Made: 04/03/2000 |
Attn: JIHAD MANSOUR |
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A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER |
A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. |
MILPITAS CA 95035 |
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AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE |
AARON MEDICAL INDUSTRIES |
7100 30TH AVE. NORTH |
ST. PETERSBURG FL 33710 -290 |
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510(k) No: K000961
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510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: RICHARD A KOZLOFF |
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FIXATION STYLETS, MODELS 335-287 AND 335-288 |
ACCUFIX RESEARCH INSTITUTE |
12503 E. EUCLID DR. # 20 |
ENGLEWOOD CO 80111 |
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510(k) No: K000366
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510(k) Statement |
SE Decision Made: 04/14/2000 |
Attn: MICHAEL J ANDREWS |
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THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 |
ACCURAY, INC. |
570 DEL REY AVE. |
SUNNYVALE CA 94085 |
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510(k) No: K000478
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510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: LUANNE NG |
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ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 |
ACRYMED, INC. |
12232 S.W. GARDEN PL. |
PORTLAND OR 97223 |
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ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS CA 95035 |
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SKYLIGHT IMAGING SYSTEM |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS CA 95035 |
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510(k) No: K000908
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: JANICE E BROWN |
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OIL FOR TISSUE CULTURE |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
3722 AVENUE SAUSALITO |
IRVINE CA 92606 |
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ABC CERVICAL PLATING SYSTEM |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO CA 94080 |
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AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR |
AGILENT TECHNOLOGIES, GMBH |
HERRENBERGERSTR. 130 |
BOEBLINGEN 71034 |
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510(k) No: K000822
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510(k) Summary |
SE Decision Made: 04/06/2000 |
Attn: EGON PFEIL |
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VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER |
AGILENT TECHNOLOGIES, INC. |
3000 MINUTEMAN RD. |
ANDOVER MA 01810 -109 |
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510(k) No: K000854
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510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: DAVE OSBORN |
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RGP MULTI-PURPOSE SOLUTION ID 100136 |
ALCON LABORATORIES |
6201 SOUTH FREEWAY R7-14 |
FORT WORTH TX 76134 -209 |
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510(k) No: K000148
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510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: RALPH H LARSEN |
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OPTI-FREE EXPRESS LENS DROPS |
ALCON UNIVERSAL, LTD. |
6201 SOUTH FREEWAY |
FORT WORTH TX 76134 -209 |
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510(k) No: K000385
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: RALPH H LARSEN |
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BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K |
MCGRAW PARK IL 60085 |
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510(k) No: K993871
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: PATRICIA SHARPE-GREGG |
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MODIFICATION TO CONVERTORS SURGICAL GOWNS |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K |
MCGRAW PARK IL 60085 |
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510(k) No: K001189
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: SHARON ROBBINS |
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DELTALOC ANTERIOR CERVICAL PLATE SYSTEM |
ALPHATEC MFG., INC. |
42-160 STATE ST. |
PALM DESERT CA 92211 -514 |
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RAPIDONE- BENZODIAZEPINE TEST |
AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW SUITE 500W |
WASHINGTON DC 20001 |
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RAPIDONE- BARBITURATE TEST |
AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW SUITE 500W |
WASHINGTON DC 20001 |
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AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
AMERIWATER |
1257 STANLEY AVE. |
DAYTON OH 45404 |
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POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. |
SYOSSET NY 11791 |
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510(k) No: K000537
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SE Decision Made: 04/27/2000 |
Attn: RICHARD KUO |
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NYLON NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. |
SYOSSET NY 11791 |
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510(k) No: K000539
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SE Decision Made: 04/27/2000 |
Attn: RICHARD KUO |
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POLYESTER NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. |
SYOSSET NY 11791 |
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510(k) No: K000540
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SE Decision Made: 04/27/2000 |
Attn: RICHARD KUO |
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SILK NONABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. |
SYOSSET NY 11791 |
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510(k) No: K000541
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: RICHARD KUO |
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PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. |
SYOSSET NY 11791 |
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510(k) No: K000542
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: RICHARD KUO |
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THERMOFLEX SYSTEM |
ARGOMED, INC. |
3800 GATEWAY CENTER BLVD. |
MORRISVILLE NC 27560 |
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510(k) No: K000508
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510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: RICHARD B KLEIN |
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TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT |
ARMKEL, LLC. |
P.O. BOX 1001, HALF ACRE RD. |
CRANBURY NJ 08512 |
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510(k) No: K000748
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510(k) Summary |
SE Decision Made: 04/06/2000 |
Attn: STEPHEN C KOLAKOWSKY |
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ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S |
ASAHI IRYOKI CO. LTD |
10 NEW KING ST. SUITE 106 |
WHITE PLAINS NY 10604 |
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510(k) No: K000740
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: MIKE PAWLUK |
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STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 |
AUTOMATIC LIQUID PACKAGING, INC. |
2200 LAKE SHORE DR. |
WOODSTOCK IL 60098 |
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510(k) No: K000964
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510(k) Summary |
SE Decision Made: 04/25/2000 |
Attn: JOHN BRDA |
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AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE |
AVID MEDICAL, INC. |
9000 WESTMONT DR. STONEHOUSE COMMERCE PARK |
TOANO VA 23168 |
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510(k) No: K000117
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510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: SEAN F SHEMANSKI |
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PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 |
AXELGAARD MFG. CO., LTD. |
329 WEST AVIATION RD. |
FALLBROOK CA 92028 -322 |
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510(k) No: K000206
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510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: DAN JEFFERY |
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BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER NY 14609 -354 |
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510(k) No: K000247
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510(k) Summary |
SE Decision Made: 04/20/2000 |
Attn: YVONNE MIDDLEFELL |
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BAYER PSA ASSAY |
BAYER CORP. |
63 NORTH ST. |
MEDFIELD MA 02052 -168 |
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BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
511 BENEDICT AVE. |
TARRYTOWN NY 10591 -509 |
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MOXIFLOXACIN, 5 UG, BBL SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
7 LOVETON CIRCLE |
SPARKS MD 21152 -099 |
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510(k) No: K000762
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510(k) Summary |
SE Decision Made: 04/25/2000 |
Attn: BRADFORD SPRING |
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GATIFLOXACIN, 5 UG, BBL SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
7 LOVETON CIRCLE |
SPARKS MD 21152 -099 |
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510(k) No: K000829
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510(k) Summary |
SE Decision Made: 04/13/2000 |
Attn: BRADFORD SPRING |
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SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 |
BREA CA 92822 -800 |
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510(k) No: K000494
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: GAIL LEFEBVRE |
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SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 |
BREA CA 92822 -800 |
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510(k) No: K000410
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510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: LUCINDA STOCKERT |
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INSYTE CATHETER, INSYTE AUTOGUARD CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY UT 84070 |
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510(k) No: K000235
|
510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: LESLIE WOOD |
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PICO SMOKERLYZER, MODEL EC-50 |
BEDFONT SCIENTIFIC LTD. |
BEDFONT HOUSE HOLYWELL LANE |
UPCHURCH, KENT ME9 7 HN |
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510(k) No: K000962
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510(k) Statement |
SE Decision Made: 04/20/2000 |
Attn: MARTIN FOXLEY |
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BETEL POWDER FREE LATEX EXAM GLOVES |
BETELCARE SDN BHD |
71/2 MILES, OFF JALAN KAPAR KAPAR |
SELANGOR DARUL EHSAN 42200 |
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510(k) No: K000650
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510(k) Statement |
SE Decision Made: 04/20/2000 |
Attn: K.B. SIAH |
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BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
BETELCARE SDN BHD |
71/2 MILES, OFF JALAN KAPAR KAPAR |
SELANGOR DARUL EHSAN 42200 |
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510(k) No: K000652
|
510(k) Statement |
SE Decision Made: 04/10/2000 |
Attn: KENG BENG SIAH |
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URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE CA 92618 -201 |
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510(k) No: K000874
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: ELIZABETH PLATT |
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ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE CA 92618 -201 |
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510(k) No: K000875
|
510(k) Summary |
SE Decision Made: 04/20/2000 |
Attn: ELIZABETH PLATT |
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ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE CA 92618 -201 |
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LAZERSMILE, LAZERWHITE |
BIOLASE TECHNOLOGY, INC. |
981 CALLE AMANECER |
SAN CLEMENTE CA 92673 |
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510(k) No: K000290
|
510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: IOANA M RIZOIU |
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DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D |
BIOMEDEX, INC. |
3380 MISTLETOE RD. |
DALLAS OR 97338 |
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510(k) No: K000299
|
510(k) Statement |
SE Decision Made: 04/28/2000 |
Attn: JAMES L THOMPSON |
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BOHN FEMORAL COMPONENT |
BIOMET MANUFACTURING, INC. |
AIRPORT INDUSTRIAL PARK P.O. BOX 587 |
WARSAW IN 46581 -058 |
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510(k) No: K000262
|
510(k) Summary |
SE Decision Made: 04/03/2000 |
Attn: TINA LAKIN |
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PEDIATRIC FIXATION RODS |
BIOMET, INC. |
P.O. BOX 587 AIRPORT INDUSTRIAL PARK |
WARSAW IN 46581 -058 |
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510(k) No: K000764
|
510(k) Summary |
SE Decision Made: 04/06/2000 |
Attn: PATRICIA SANDBORN BERES |
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ASCENT KNEE REVISION FEMORAL STEM |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, P.O.BOX 587 |
WARSAW IN 46581 -058 |
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MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, P.O.BOX 587 |
WARSAW IN 46581 -058 |
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510(k) No: K990830
|
510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: PATRICIA SANDBORN BERES |
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EMBOSPHERE MICROSPHERES |
BIOSPHERE MEDICAL |
1050 HINGHAM ST. |
ROCKLAND MA 02370 |
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PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 |
BIOTRONIK, GMBH & CO. |
6024 JEAN RD. |
LAKE OSWEGO OR 97035 |
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510(k) No: K000763
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SE Decision Made: 04/06/2000 |
Attn: Jon Brumbaugh |
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EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 |
BIOTRONIK, INC. |
6024 JEAN ROAD |
LAKE OSWEGO OR 97035 |
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VIP- VARIABLE INTENSITY POLYMERIZER |
BISCO, INC. |
1100 WEST IRVING PARK RD. |
SCHAUMBURG IL 60193 |
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510(k) No: K000426
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: KATHRYN B PATTERSON |
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BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick MA 01760 |
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510(k) No: K000570
|
510(k) Summary |
SE Decision Made: 04/13/2000 |
Attn: TERRY A MCGOVERN |
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TRANSLUMINAL BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK MA 01760 -153 |
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RENEGADE HI-FLO MICROCATHETER |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick MA 01760 |
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510(k) No: K000177
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: TERRY A MCGOVERN |
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MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE MN 55311 |
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510(k) No: K000956
|
510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: MELANIE RASKA |
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JET PORT PLUS CATHETER SYSTEM |
CLINICAL PLASTIC PRODUCTS SA |
154 VIA LAMPARA |
RANCHO SANTA MARGARITA CA 92688 |
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510(k) No: K000125
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: SALVADORE F PALOMARES |
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COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR |
COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY |
ARVADA CO 80004 |
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510(k) No: K000255
|
510(k) Summary |
SE Decision Made: 04/25/2000 |
Attn: LYNNE LEONARD |
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TENAX WHITE POST |
COLTENE/WHALEDENT INC. |
750 CORPORATE DR. |
MAHWAH NJ 07430 -200 |
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CTC DVT-1 CALF GARMENT, MODEL DVT-1 |
COMPRESSION THERAPY CONCEPTS, INC. |
3614 KENNEDY RD. |
SOUTH PLAINFIELD NJ 07080 |
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510(k) No: K000147
|
510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: J. JAMES BRITTON |
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ENHANCED COMPENSATING FILTER |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
1195 CORPORATE LAKE DR. |
ST. LOUIS MO 63132 -171 |
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510(k) No: K000137
|
510(k) Summary |
SE Decision Made: 04/17/2000 |
Attn: MICHAEL A PARSONS |
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QUALITROL LIPID CONTROL, LEVELS 1 AND 2 |
CONSOLIDATED TECHNOLOGIES OF WISCONSIN |
2170 WOODWARD ST. |
AUSTIN TX 78744 -183 |
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510(k) No: K000810
|
510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: RUSTY SEWELL |
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|
CSM STRETTA SYSTEM |
CONWAY STUART MEDICAL, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON DC 20004 -110 |
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|
510(k) No: K000245
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: JONATHAN S KAHAN |
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|
CORDIS INTRODUCER GUIDE |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES FL 33014 |
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|
510(k) No: K001136
|
510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: ARIEL MACTAVISH |
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|
CORDIS 13F CATHETER SHEATH INTRODUCER |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES FL 33014 |
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|
510(k) No: K000753
|
510(k) Summary |
SE Decision Made: 04/06/2000 |
Attn: ARIEL MACTAVISH |
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|
AGILITY STEERABLE GUIDEWIRE |
CORDIS NEUROVASCULAR, INC. |
14000 N.W. 57TH CT. |
MIAMI LAKES FL 33014 |
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|
510(k) No: K001033
|
510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: MARITZA CELAYA |
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|
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
12061 TEJON ST. |
WESTMINSTER CO 80234 |
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|
510(k) No: K000920
|
510(k) Summary |
SE Decision Made: 04/26/2000 |
Attn: NANCI DEXTER |
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CORTEK ARTHROSCOPE |
CORTEK ENDOSCOPY, INC. |
501 W. COLFAX, SUITE B |
PALATINE IL 60067 |
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|
510(k) No: K000198
|
510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: CORNEL M TOPALA |
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|
CORTEK MINI LAPAROSCOPE |
CORTEK ENDOSCOPY, INC. |
501 W. COLFAX, SUITE B |
PALATINE IL 60067 |
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|
510(k) No: K000199
|
510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: CORNEL M TOPALA |
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|
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES |
COULTER CORP. |
11800 S.W. 147TH AVE. MAIL CODE 31-B06 |
MIAMI FL 33196 -250 |
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|
8100 VITAL SIGNS MONITOR |
CRITICARE SYSTEMS, INC. |
20925 CROSSROADS CIRCLE |
WAUKESHA WI 53186 |
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|
510(k) No: K001020
|
510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: ALEX KAPLAN |
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|
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS |
CRYSTAL REFLECTIONS, INT., INC. |
1325 PROGRESS DR. |
FRONT ROYAL VA 22630 |
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|
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000464
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000466
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000467
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000458
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510(k) Summary |
SE Decision Made: 04/17/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000459
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510(k) Summary |
SE Decision Made: 04/03/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000460
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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510(k) No: K000461
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510(k) Summary |
SE Decision Made: 04/06/2000 |
Attn: JUDY MCINNIS-BERGER |
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URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK DE 19714 |
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SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
7739 NW 48 ST. SUITE 120 |
MIAMI FL 33166 |
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510(k) No: K000649
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510(k) Summary |
SE Decision Made: 04/25/2000 |
Attn: RADAMES RIESGO |
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CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) |
DATEX-OHMEDA |
THREE HIGHWOOD DR. |
TEWKSBURY MA 01876 |
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510(k) No: K000168
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510(k) Summary |
SE Decision Made: 04/13/2000 |
Attn: JOEL KENT |
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DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA |
DATEX-OHMEDA, INC. |
P.O. BOX 7550 |
MADISON WI 53707 -755 |
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510(k) No: K000275
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: DANIEL KOSEDNAR |
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DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY MA 01876 |
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DATES-OHMEDA AESTIVA SMARTVENT MRI |
DATEX-OHMEDA, INC. |
OHMEDA DR. P.O. BOX 7550 |
MADISON WI 53707 -755 |
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ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 |
DENTSPLY INTL. |
901 WEST OAKTON ST. |
DES PLAINES IL 60018 -188 |
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510(k) No: K000112
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510(k) Summary |
SE Decision Made: 04/13/2000 |
Attn: WILLIAM T COUSINS |
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MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM MA 02767 -035 |
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510(k) No: K001105
|
510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: LISA GILMAN |
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RESPONSE 2000 HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW IN 46581 -098 |
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RESPONSE 2000 CEMENTED HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW IN 46581 -098 |
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MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
4029 CHARIOT'S FLIGHT WAY |
ELLICOTT CITY MD 21042 |
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510(k) No: K001118
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510(k) Summary |
SE Decision Made: 04/25/2000 |
Attn: JUDITH J SMITH |
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LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 |
DIDECO S.P.A. |
195 WEST ST. |
WALTHAM MA 02451 -116 |
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510(k) No: K001021
|
510(k) Summary |
SE Decision Made: 04/25/2000 |
Attn: BARRY SALL |
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LUXAFORM |
DMG USA, INC. |
5 WHITCOMB AVE. |
AYER MA 01432 |
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510(k) No: K000951
|
510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: PAMELA PAPINEAU |
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HONIGUM |
DMG USA, INC. |
5 WHITCOMB AVE. |
AYER MA 01432 |
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510(k) No: K000878
|
510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: PAMELA PAPINEAU |
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IQ CHAMBERS |
DORMER LABORATORIES, INC. |
2000 M. ST., N.W., 7TH FLOOR |
WASHINGTON DC 20036 -330 |
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DRG AURICA ELISA TESTOSTERONE KIT |
DRG INTL., INC. |
150 CHERRY LANE RD. |
EAST STROUDSBURG PA 18301 |
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510(k) No: K000043
|
510(k) Summary |
SE Decision Made: 04/17/2000 |
Attn: NIKOLAS BUTKOV |
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SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000522
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: PATRICK BEENTJES |
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SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000350
|
510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: PATRICK BEENTJES |
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SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000400
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: PATRICK BEENTJEES |
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SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000402
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: PATRICK BEENTJES |
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SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000273
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: PATRICK BEENTJES |
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SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000449
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: PATRICK BEENTJES |
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SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST |
DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT SUITE A-7 |
ALPHARETTA GA 30005 |
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510(k) No: K000452
|
510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: PATRICK BEENTJES |
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STERILE WATER & STERILE 0.9% SODIUM CHLORIDE |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
104 SHORTING ROAD |
TORONTO, ONTARIO M1S 3 S4 |
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MODIFICATION TO EBI SPINELINK SYSTEM |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY NJ 07054 |
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510(k) No: K001037
|
510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JONAS WILF |
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STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
ELA MEDICAL, INC. |
2950 XENIUM LN. NORTH, #120 |
PLYMOUTH MN 55441 |
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STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
ELA MEDICAL, INC. |
2950 XENIUM LN. NORTH |
PLYMOUTH MN 55441 |
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510(k) No: K000029
|
510(k) Summary |
SE Decision Made: 04/04/2000 |
Attn: CATHERINE G GOBLE |
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VIEW NT |
ELECTROMED INTL., LTD. |
310 INDUSTRIAL BLVD. |
ST-EUSTACHE, QUEBEC J7R 5 R4 |
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510(k) No: K000474
|
510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: PASCAL M KAUFMANN |
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BIOLOK SCREW |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN TX 78758 |
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INCENTIVE SPIROMETER |
ENGINEERED MEDICAL SYSTEMS |
2055 EXECUTIVE DR. |
INDIANAPOLIS IN 46241 |
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510(k) No: K000314
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: BONNIE HOLLY |
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DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE |
ENTERIC MEDICAL TECHNOLOGIES |
1125 EAST HILLSDALE BLVD. SUITE 106 |
FOSTER CITY CA 94404 |
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510(k) No: K000646
|
510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: JILL M VISOR |
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ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER |
ERCHINGER MEDIZINTECNIK |
AMSTEL 320 I |
AMSTERDAM 1017 AP |
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510(k) No: K000297
|
510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: DAGMAR MASER |
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DIMENSION PENTA L |
ESPE DENTAL AG |
ESPE PLATZ |
SEEFELD, BAVARIA D-822 29 |
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510(k) No: K000595
|
510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: ANDREAS PETERMANN |
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EVERSHEARS BIPOLAR SCISSORS |
EVEREST MEDICAL CORP. |
13755 FIRST AVENUE, NORTH, SUITE 500 |
MINNEAPOLIS MN 55441 -544 |
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510(k) No: K000496
|
510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: FREDERICK G MADES |
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VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED |
EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD. |
THE NORTH OF BEISHIMEN VILLAGE #1,EVERGREEN RD., XIAZUO TOWN |
SHIJIAZHUANG CITY,HEBEI PROV. 05030 6 |
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EEG WITH VIDEO, MODEL EX-NW |
EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE |
OAKVILLE, ONTARIO L6H 5S1 |
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510(k) No: K000898
|
510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: DEBBIE DAVY |
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BIOCERAMIC ORBITAL IMPLANT |
FCI OPHTHALMICS, INC. |
P.O. BOX 465 76 PROSPECT ST. |
MARSHFIELD HILLS MA 02051 |
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PACSSTATION |
FERNANDEZ INDUSTRIES, INC. |
35 VINE ST. # 204 |
WINCHESTER MA 01890 |
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510(k) No: K000448
|
510(k) Summary |
SE Decision Made: 04/20/2000 |
Attn: ANTHONY FERNANDEZ |
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STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES |
FITCO DIPPED PRODUCTS PVT. LTD |
14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, KOCHIN |
KERALA 682 0 30 |
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510(k) No: K000891
|
510(k) Statement |
SE Decision Made: 04/28/2000 |
Attn: JOSEPH J E PEREIRA |
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POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
FITCO DIPPED PRODUCTS PVT. LTD |
14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, COCHIN |
KERALA 682 0 30 |
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510(k) No: K001216
|
510(k) Statement |
SE Decision Made: 04/28/2000 |
Attn: JOSEPH J E PEREIRA |
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LORAD LT-100 LASER TREATMENT SYSTEM |
FOCUS MEDICAL, LLC. |
39 SILVER SPRING PARK |
RIDGEFIELD CT 06877 |
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DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
STEGNE 7, |
LJUBLJANA 1210 |
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510(k) No: K000106
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: MOJCA VALJAVEC |
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FRIALIT-2 MH-2 ABUTMENT |
FRIADENT GMBH |
21911 ERIE LN. |
LAKE FOREST CA 92630 |
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FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND WA 98052 -491 |
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510(k) No: K000746
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: DAVID J GERAGHTY |
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FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT |
FUTURE DIAGNOSTICS B.V. |
4079 MT. BARNARD |
SAN DIEGO CA 92111 |
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510(k) No: K000471
|
510(k) Statement |
SE Decision Made: 04/11/2000 |
Attn: DAVE D SMITH |
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SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM |
GE DEC MEDICAL SYSTEMS |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY UT 84116 |
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510(k) No: K000221
|
510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: TED L PARROT |
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GE LOGIQ 700 |
GE MEDICAL SYSTEMS |
P.O. BOX 414 |
MILWAUKEE WI 53188 |
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510(k) No: K000571
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: ALLEN SCHUH |
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GE LOGIQ 700 |
GE MEDICAL SYSTEMS |
P.O. BOX 414 |
MILWAUKEE WI 53188 |
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510(k) No: K001016
|
510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: ALLEN SCHUH |
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GE LOGIQ 700 |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE WI 53201 |
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|
510(k) No: K000516
|
510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: ALLEN SCHUH |
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GETTIG GUARD |
GETTIG PHARMACEUTICAL INSTRUMENT CO. |
55 Northern Blvd. Suite 200 |
Great Neck NY 11021 |
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510(k) No: K000455
|
510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: JAMES A BENZ |
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GT990402 DIGITAL THERMOMETER |
GLOBAL TREASURE LTD. |
BLOCK2, 5/F,. ROOM 8 NAN FUNG IND. CITY |
18 TIN HAU ROAD, TUEN MUN N.T. |
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510(k) No: K001279
|
510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: BEN MA |
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|
GSI 2000 MIDDLE EAR ANALYZER |
GRASON-STADLER, INC. |
1 WESTCHESTER DR. |
MILFORD NH 03055 -305 |
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510(k) No: K000097
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: NORMAN L SCHULTZ |
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1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
26531 YNEZ RD. |
TEMECULA CA 92591 -463 |
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510(k) No: K000793
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: BYRON LAMBERT |
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|
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK NY 11021 |
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|
510(k) No: K001047
|
510(k) Statement |
SE Decision Made: 04/28/2000 |
Attn: SUSAN D GOLDSTEIN-FALK |
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|
WEHRS INCUS-STAPES |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT TN 38133 |
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|
510(k) No: K000858
|
510(k) Summary |
SE Decision Made: 04/03/2000 |
Attn: ALICIA FARAGE |
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|
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE |
GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS |
CARDIFF CF3 0 LT |
|
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|
510(k) No: K001270
|
510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: DAVID KAY |
|
|
|
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 |
HAEMACURE CORP. |
2 NORTH TAMIAMI TRAIL, #802 |
SARASOTA FL 34236 |
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|
|
HARDYDISK, CEFOTAXIME 30MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
|
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|
510(k) No: K000524
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
|
|
|
HARDYDISK OFLOXACIN 5MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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|
510(k) No: K000525
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
|
|
|
HARDYDISK, CEPHALOTHIN 30MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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|
510(k) No: K000526
|
510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: MELISSA M TRAYLOR |
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|
|
HARDYDISK, VANCOMYCIN 30MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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|
510(k) No: K000509
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
|
|
|
HARDYDISK CEFTRIAXONE 30MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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|
510(k) No: K000440
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
|
|
|
HARDYDISK, AMPICILLIN, 10MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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|
|
510(k) No: K000268
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
|
|
|
HARDYDISK, SULFA/TRIMETH |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
|
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|
510(k) No: K000271
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
|
|
|
HARDYDISK, NITROFURANTOIN |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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510(k) No: K000272
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510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
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HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG |
HARDY DIAGNOSTICS |
1430 WEST MCCOY LN. |
SANTA MARIA CA 93455 |
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510(k) No: K000261
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510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: MELISSA M TRAYLOR |
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ACTIVATOR PASTE |
HARRY J. BOSWORTH CO. |
7227 NORTH HAMLIN AVE. |
SKOKIE IL 60076 |
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510(k) No: K994027
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510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: MILDRED M GOLDSTEIN |
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KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I |
AMSTERDAM 1017 AP |
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510(k) No: K000127
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: DAGMAR MASER |
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KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I |
AMSTERDAM 1017 AP |
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510(k) No: K001123
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: DAGMAR S MASER |
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SPIFE CHOLESTEROL PROFILE KIT |
HELENA LABORATORIES |
1530 LINDBERGH DR. P.O. BOX 752 |
BEAUMONT TX 77704 |
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510(k) No: K000603
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510(k) Statement |
SE Decision Made: 04/17/2000 |
Attn: ERIC PETERSEN |
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ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST |
HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. |
WEST SACRAMENTO CA 95691 -622 |
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510(k) No: K000489
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510(k) Statement |
SE Decision Made: 04/05/2000 |
Attn: VIRGINIA CAPPEL |
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FLEXTIME |
HERAEUS KULZER, INC. |
4315 SOUTH LAFAYETTE BLVD. |
SOUTH BEND IN 46614 -251 |
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510(k) No: K000629
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510(k) Statement |
SE Decision Made: 04/05/2000 |
Attn: CHERYL V ZIMMERMAN |
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TI500 GLOBE-TROTTER TRANSPORT SYSTEM |
HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. |
HATBORO PA 19040 |
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510(k) No: K001019
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510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: JAMES G CARPENTER |
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HMS NEUROMUSCULAR STIMULATOR |
HOME MEDICAL SERVICES, INC. |
9393 ACTIVITY RD. SUITE F |
SAN DIEGO CA 92126 |
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MS-ONE, MODEL MS-1 |
HOME WELLNESS WEST |
9393 ACTIVITY RD. SUITE F |
SAN DIEGO CA 92126 |
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ASNIS III CANNULATED SCREW SYSTEM |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE NJ 07401 -167 |
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510(k) No: K000080
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510(k) Summary |
SE Decision Made: 04/03/2000 |
Attn: MARY-CATHERINE DILLON |
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HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) |
HWA TEH INDUSTRIAL SDN. BHD. |
LOT 187, SUNGAI DAHAR |
BATANG BERJUNTAI 45600 |
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510(k) No: K000725
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510(k) Statement |
SE Decision Made: 04/05/2000 |
Attn: K. KARUNAKARAN |
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MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 |
HYSTERX, INC. |
18732 SAGINAW |
IRVINE CA 92612 |
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510(k) No: K000911
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JUDY F GORDON |
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LIGA-LOOP SUTURE APPLICATOR |
HYSTERX, INC. |
18732 SAGINAW |
IRVINE CA 92612 |
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I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER |
I-STAT CORP. |
104 WINDSOR CENTER DR. |
EAST WINDSOR NJ 08520 |
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510(k) No: K001154
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510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: PAUL VANDERWERF |
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IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS |
IDEMSA |
1600 STEWART AVE. |
WESTBURY NY 11590 |
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CRANIAL DRILL |
IMAGE-GUIDED NEUROLOGICS, INC. |
2290 W. EAU GALLIE BLVD. SUITE 210 |
MELBOURNE FL 32935 |
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510(k) No: K000195
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510(k) Statement |
SE Decision Made: 04/20/2000 |
Attn: DAVID M LEE |
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ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE |
INRAD |
3956 44TH ST., S.E. |
KENTWOOD MI 49512 |
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510(k) No: K000612
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510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: JOSEPH M MAZUREK |
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PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE |
INTEGRATED ORBITAL IMPLANTS, INC. |
4329 GRAYDON RD. |
SAN DIEGO CA 92130 |
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510(k) No: K000151
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510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: FLOYD G LARSON |
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HAIDER-UCR SPINAL SYSTEM |
INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. |
200 GREGORY LN. SUITE C-100 |
PLEASANT HILL CA 94523 |
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SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP |
INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. |
IRVINE CA 92618 -240 |
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510(k) No: K000876
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510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: LYNN M RODARTI |
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939UDX URINE PATHOLOGY SYSTEM |
INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. |
CHATSWORTH CA 91311 |
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510(k) No: K000373
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: HARVEY L KASDAN |
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INTRASTENT DOUBLESTRUT XS STENT |
INTRATHERAPEUTICS, INC. |
651 CAMPUS DR. |
ST. PAUL MN 55112 |
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510(k) No: K000864
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: MARIA E BRITTLE |
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SUTUREGROOVE |
IOP, INC. |
3151 AIRWAY AVE., BLDG. I-1 |
COSTA MESA CA 92626 |
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SAMPLOK |
ITL CORPORATION, PTY LTD. |
15825 SHADY GROVE RD. SUITE 90 |
ROCKVILLE MD 20850 |
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510(k) No: K000777
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510(k) Statement |
SE Decision Made: 04/11/2000 |
Attn: KENNETH A PALMER |
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JELDENT BASIC LINE |
J.F. JELENKO & CO. |
99 BUSINESS PARK DR. |
ARMONK NY 10504 |
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510(k) No: K000213
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510(k) Statement |
SE Decision Made: 04/06/2000 |
Attn: RAPHAEL JUDKINS |
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JEL 15 |
J.F. JELENKO & CO., INC. |
99 BUSINESS PARK DR. |
ARMONK NY 10504 |
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510(k) No: K000532
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510(k) Statement |
SE Decision Made: 04/06/2000 |
Attn: RAPHAEL JUDKINS |
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SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES |
JB STAR SDN BHD |
3A JALAN CEKOR, TAMAN SRI AMAR |
JOHOR BARUE, JOHOR 81100 |
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510(k) No: K001094
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510(k) Statement |
SE Decision Made: 04/28/2000 |
Attn: LOOI CHIN SWEE |
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RX EVEREST |
JENERIC/PENTRON, INC. |
53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 |
WALLINGFORD CT 06492 -072 |
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510(k) No: K001051
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: ANNMARIE TENERO |
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MODIFICATION TO JMS APHERESIS NEEDLE |
JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU |
HIROSHIMA 730-8 652 |
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510(k) No: K000843
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510(k) Statement |
SE Decision Made: 04/10/2000 |
Attn: KEISUKE URATOMI |
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MODIFICATION TO JMS A.V. FISTULA NEEDLE SET |
JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU |
HIROSHIMA 730-8 652 |
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510(k) No: K000845
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510(k) Statement |
SE Decision Made: 04/10/2000 |
Attn: KEISUKE URATOMI |
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SIPHONGUARD CSF CONTROL DEVICE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM MA 02767 -035 |
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K-ASSAY AT-III |
KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. |
SEATTLE WA 98188 -341 |
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510(k) No: K000361
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510(k) Statement |
SE Decision Made: 04/26/2000 |
Attn: COLIN GETTY |
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KSEA CHARDONNES MORCELLATION KNIFE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY CA 90230 -760 |
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510(k) No: K000212
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: KEVIN KENNAN |
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EZ CONNECT RESIN |
KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. |
ORANGE CA 92867 |
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510(k) No: K000357
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: COLLEEN BOSWELL |
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EZ CONNECT |
KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. |
ORANGE CA 92867 |
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510(k) No: K000346
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: COLLEEN BOSWELL |
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REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) |
LONDON INTERNATIONAL GROUP, INC. |
P.O. BOX 8308 2926 COLUMBIA HIGHWAY |
DOTHAN AL 36304 |
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PRODIGY LATERAL VIEW SOFTWARE |
LUNAR CORP. |
726 HEARTLAND TRAIL |
MADISON WI 53717 |
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510(k) No: K000826
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JAMES P RASKOB |
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MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT |
MALLINCKRODT DAR S.R.L. |
VIA G.BOVE, 2/4/6/8 |
MIRANDOLA (MODENA) 41037 |
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MEDISUL DISPOSABLE VAGINAL SPECULUM |
MARKETING PERSPECTIVES |
6565 146TH AVE. |
HOLLAND MI 49423 |
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510(k) No: K000414
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510(k) Summary |
SE Decision Made: 04/04/2000 |
Attn: JIMMIE D WILSON |
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E3 MICROPROB SERIES OF LASERS AND ACCESSORIES |
MARTIN URAM, MD |
39 SYCAMORE AVE. |
LITTLE SILVER NJ 07739 -120 |
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510(k) No: K000192
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510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: MARTIN URAM |
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MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA |
MASIMO CORP. |
2852 KELVIN AVE. |
IRVINE CA 92614 -582 |
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510(k) No: K000126
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JAMES J CRONIN |
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MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS |
MATANG MFG. SDN. BHD. |
6324 MEETING HOUSE WAY |
ALEXANDRIA VA 22312 -171 |
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510(k) No: K000985
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510(k) Statement |
SE Decision Made: 04/24/2000 |
Attn: KOK-KEE HON |
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MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 |
MATSUSHITA ELECTRIC CORP. OF AMERICA |
1730 PENNSYLVANIA AVE., N.W. |
WASHINGTON DC 20006 -470 |
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THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE |
MDS NORDION |
447 MARCH RD. |
OTTAWA, ONTARIO K2K1X 8 |
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510(k) No: K001006
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510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: E S MARTELL |
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WILSON-COOK COLONIC Z-STENT |
MED INSTITUTE, INC. |
1400 CUMBERLAND AVE. P.O. BOX 2402 |
WEST LAFAYETTE IN 47906 |
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PERCUTANEOUS INTRODUCER, MODEL 10383-XXX |
MEDAMICUS, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS MN 55447 |
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510(k) No: K000824
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510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: DENNIS MADISON |
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MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES |
MEDICAL ADVANCES, INC. |
10437 INNOVATION DR. |
MILWAUKEE WI 53226 |
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510(k) No: K000345
|
510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: THOMAS E TYNES |
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PORTABLE INTENSIVE CARE UNIT, MODEL PIC |
MEDICAL RESEARCH LABORATORIES, INC. |
1000 ASBURY DR. NO.17 |
BUFFALO GROVE IL 60089 |
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510(k) No: K000712
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510(k) Statement |
SE Decision Made: 04/27/2000 |
Attn: JOEL ORLINSKY |
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PERITONEAL DIALYSIS CATHETERS AND ADAPTERS |
MEDIONICS INTERNATIONAL, INC. |
114 ANDERSON AVE. |
MARKHAM, ONTARIO L6E 1 A5 |
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MEDLINE TENDER WET WOUND DRESSING |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN IL 60060 |
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MEDTRADE PRODUCTS ALGINATE ISLAND |
MEDTRADE PRODUCTS LTD. |
ELECTRA HOUSE CREWE BUSINESS PARK |
CREWE, CHESHIRE CW1 6 GL |
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510(k) No: K000487
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510(k) Statement |
SE Decision Made: 04/18/2000 |
Attn: JONATHAN RANFIELD |
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MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
620 WATSON S.W. |
GRAND RAPIDS MI 49504 |
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MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS TN 38132 |
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510(k) No: K000991
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: RICHARD W TREHARNE |
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AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 |
MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. |
ANAHEIM CA 92807 |
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510(k) No: K001138
|
510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: MARIE HOLM |
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MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), |
MEDTRONIC VASCULAR |
11660 WAYZATA BLVD. |
MINNETONKA MN 55305 |
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510(k) No: K000105
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: PAM SCHAUB |
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MEDTRONIC MODEL 7499 EXTENSION |
MEDTRONIC VASCULAR |
800 53RD AVENUE, NE P.O. BOX 1250 |
MINNEAPOLIS MN 55440 -908 |
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510(k) No: K000445
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: Kathy Jo Fahey |
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MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT |
MEDTRONIC VASCULAR |
620 WATSON STRET S.W. |
GRAND RAPIDS MI 49504 |
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MDI SCL-70 TEST |
MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 |
TUSTIN CA 92780 -703 |
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510(k) No: K000934
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: MEHDI ALEM |
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RENAFLO II HF 2000 HEMOFILTER |
MINNTECH CORP. |
14905 28TH AVE. N. |
MINNEAPOLIS MN 55447 |
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MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT |
MINXRAY, INC. |
3611 COMMERCIAL AVE. |
NORTHBROOK IL 60062 |
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510(k) No: K000061
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: KEITH KRETCHMER |
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VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
60 GLACIER DR. |
WESTWOOD MA 02090 |
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510(k) No: K000936
|
510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: MARY P LEGRAW |
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KFA-63 KNEE AND FOOT ARRAY |
MRI DEVICES CORP. |
1515 PARAMOUNT DR. |
WAUKESHA WI 53186 |
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510(k) No: K000935
|
510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: THOMAS SCHUBERT |
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HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G |
MRL DIAGNOSTICS |
10703 PROGRESS WAY |
CYPRESS CA 90630 -473 |
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510(k) No: K000238
|
510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: MICHAEL J WAGNER |
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MTP DISPOSABLE TROCAR VALVES |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
600 CORPORATE POINTE |
CULVER CITY CA 90230 |
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510(k) No: K000337
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: KEVIN KENNAN |
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UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES |
N.S. UNI-GLOVES SDN. BHD. |
UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 |
TORRANCE CA 90501 |
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510(k) No: K000688
|
510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: ROBERT D VANDER LEEK |
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UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES |
N.S. UNI-GLOVES SDN. BHD. |
UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 |
TORRANCE CA 90501 |
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510(k) No: K000689
|
510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: ROBERT D VANDER LEEK |
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3D MANUAL COARSE MANIPULATOR MN-188NE |
NARISHIGE CO., LTD. |
27-9 MINAMIKARASUYAMA 4-CHOME |
SETAGAY-KU, TOKYO 157-0 062 |
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510(k) No: K001130
|
510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: MITSUKO YONEYAMA |
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3D HDRAULIC FINE MICROMANIPULATOR MO-188NE |
NARISHIGE CO., LTD. |
27-9 MINAMIKARASUYAMA 4-CHOME |
SETAGAY-KU, TOKYO 157-0 062 |
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510(k) No: K001131
|
510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: MITSUKO YONEYAMA |
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CARDIO-CARD INTERPRETATION SYSTEM I |
NASIFF ASSOC., INC. |
9422 LEBEAU LN. |
BREWERTON NY 13029 |
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QUIK-CAP |
NEUROSCAN |
45150 BUSINESS CT., SUITE 100 |
STERLING VA 20166 |
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510(k) No: K000865
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: DAVID B JONES |
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|
VITAPORT 3 |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE CA 92612 -160 |
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510(k) No: K000338
|
510(k) Summary |
SE Decision Made: 04/26/2000 |
Attn: BONNIE BISHOP |
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|
STAT PROFILE PHOX PLUS ANALYZER |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM MA 02454 -914 |
|
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|
510(k) No: K000895
|
510(k) Statement |
SE Decision Made: 04/17/2000 |
Attn: PAUL W MACDONALD |
|
|
|
MODIFICATION TO MARSPO2, MODEL 2001 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
56 CARPENTER LN. |
WALLINGFORD CT 06492 |
|
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|
510(k) No: K000794
|
510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: ROBERT H SCHIFFMAN |
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|
SOFTLINE SPRING CLIP |
NOVARE SURGICAL SYSTEMS, INC. |
10231 BUBB RD. |
CUPERTINO CA 95014 |
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510(k) No: K000098
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: TERRY BUELNA |
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NUVASIVE TOWNLEY FACET SCREW |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO CA 92131 |
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OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM |
OPTIMAL IMAGING SYSTEMS, INC. |
9344 NW 13TH ST. SUITE 200 |
MIAMI FL 33172 |
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510(k) No: K000415
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510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: JORGE MILLAN |
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STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I |
ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. |
BETHLEHEM PA 18018 -179 |
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STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I |
ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. |
BETHLEHEM PA 18018 -179 |
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TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 |
ORIENTAL SYSTEM TECHNOLOGY, INC. |
55 Northern Blvd. Suite 200 |
Great Neck NY 11021 |
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510(k) No: K001008
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: SUSAN D GOLDSTEIN-FALK |
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HEMISPHERE MODULAR CUP SYSTEM |
ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH |
DRAPER UT 84020 |
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510(k) No: K000321
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510(k) Statement |
SE Decision Made: 04/10/2000 |
Attn: CAROL FREASIER |
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VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. |
ROCHESTER NY 14626 -510 |
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510(k) No: K001133
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510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: MARLENE SHULMAN |
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OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
15990 N GREENWAY-HAYDEN LOOP SUITE 100 |
SCOTTSDALE AZ 85260 |
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510(k) No: K000797
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510(k) Summary |
SE Decision Made: 04/03/2000 |
Attn: MELODY F MARTIN |
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5.0MM SPINAL SCREWS |
ORTHOTEC, L.L.C. |
200 GREGORY LN. SUITE C-100 |
PLEASANT HILL CA 94523 -338 |
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APPRAISE-CARDIO SAMPLE COLLECTION KIT |
OSBORN GROUP, INC. |
14901 WEST 117TH ST. |
OLATHE KS 66062 |
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OSTEONICS SERIES 7000 AD TIBIAL TRAY |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE NJ 07401 -167 |
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MODEL 120 |
PALCO LABS, INC. |
8030 SOQUEL AVE. |
SANTA CRUZ CA 95062 |
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HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES |
PAMITEX INDUSTRIES SDN BHD |
2 1/2 MILES, JALAN RASAH SEREMBAN, NAGERI SEMBILAN |
DARUL KHUSUS 70300 |
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HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE |
PAMITEX INDUSTRIES SDN BHD |
2 1/2 MILES, JALAN RASAH SEREMBAN, NAGERI SEMBILAN |
DARUL KHUSUS 70300 |
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510(k) No: K000828
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510(k) Statement |
SE Decision Made: 04/07/2000 |
Attn: SAID AWANG |
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FLUROPERM 60-OK, PARAGON HDS-OK |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE. |
MESA AZ 85204 |
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510(k) No: K000224
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510(k) Summary |
SE Decision Made: 04/17/2000 |
Attn: WILLIAM E MEYERS |
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STEROTACTIC LOCALIZATION DEVICE (SLD) |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
710 BRIDGEPORT AVE. |
SHELTON CT 06484 |
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510(k) No: K000832
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510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: PETER A LTMAN |
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NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE |
PHOENIX MEDICAL TECHNOLOGY, INC. |
HWY. 521 WEST, P.O. BOX 346 |
ANDREWS SC 29510 |
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510(k) No: K000223
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510(k) Statement |
SE Decision Made: 04/14/2000 |
Attn: GROVER C MIXON |
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DIXI 2 |
PLANMECA OY |
ASENTAJANKATU 6 |
HELSINKI 00880 |
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510(k) No: K000428
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510(k) Statement |
SE Decision Made: 04/28/2000 |
Attn: LARS MORING |
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PM 2002 PROLINE/AEC |
PLANMECA OY |
ASENTAJANKATU 6 |
HELSINKI 00880 |
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510(k) No: K000163
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510(k) Statement |
SE Decision Made: 04/18/2000 |
Attn: LARS MORING |
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BICON-PLUS ACETABULAR COMPONENTS |
PLUS ORTHOPEDICS |
3550 GENERAL ATOMICS CT. BLDG. 15-100 |
SAN DIEGO CA 92121 -112 |
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UMBICUT |
POLLAK (INTL.), LTD. |
HAMLACHA 20, INDUSTRIAL ZONE |
ROSH HA'AYIN 48091 |
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510(k) No: K000227
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510(k) Statement |
SE Decision Made: 04/27/2000 |
Attn: MICHAEL PORAT |
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POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 |
POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. |
MINNEAPOLIS MN 55433 -800 |
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POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C |
POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. |
MINNEAPOLIS MN 55433 -800 |
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MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM |
PRISM ENTERPRISES, INC. |
10 AUBREY COURT |
SAN ANTONIO TX 78216 |
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510(k) No: K000444
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: JUDITH A HARBOUR |
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PRO.DUCT CATHETER, MODEL CTH03 |
PRO.DUCT HEALTH, INC. |
1010 HAMILTON CT. |
MENLO PARK CA 94025 |
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510(k) No: K000135
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510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: ANGELA B SOITO |
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POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM |
PROTECTION GLOVES SDN. BHD. |
LOT NO. 236, BATU 2 1/2, JALAN YONG PENG |
CHAAH, JOHOR 85400 |
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510(k) No: K000667
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: THIRUNAVUKARASU PEARIASAMY |
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POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA |
PROTECTION GLOVES SDN. BHD. |
LOT NO. 236, BATU 2 1/2, JALAN YONG PENG |
CHAAH, JOHOR 85400 |
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510(k) No: K000668
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510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: THIRUNAVUKARASU PEARIASAMY |
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PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 |
PRUCKA ENGINEERING, INC. |
13000 EXECUTIVE DR. |
SUGAR LAND TX 77478 |
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PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM |
PURE WATER, INC. |
305 WEST MARKET ST. |
ANDERSON SC 29624 |
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REMOTE FETAL MEDICINE ULTRASOUND SYSTEM |
R4 TELEMEDICINE, INC. |
1301 K ST. N.W. SUITE 800 EAST |
WASHINGTON DC 20005 -333 |
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510(k) No: K000443
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510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: THOMAS B SMITH |
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RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR |
RADIOTHERAPEUTICS CORP. |
1308 BORREGAS AVE.SUITE 200 |
SUNNYVALE CA 94089 |
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510(k) No: K000241
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510(k) Statement |
SE Decision Made: 04/14/2000 |
Attn: GARY CURTIS |
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LEVEEN NEEDLE ELECTRODE |
RADIOTHERAPEUTICS CORP. |
2685 MARINE WAY, SUITE 1408 |
MOUNTAIN VIEW CA 94043 |
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RANDOX CALCIUM |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, CO. ANTRIM BT29 4QY |
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510(k) No: K000375
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510(k) Statement |
SE Decision Made: 04/05/2000 |
Attn: P. ARMSTRONG |
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RANDOX PREALBUMIN |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, CO. ANTRIM BT29 4QY |
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510(k) No: K000661
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510(k) Statement |
SE Decision Made: 04/13/2000 |
Attn: P ARMSTRONG |
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RANDOX FERRITIN |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, CO. ANTRIM BT29 4QY |
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510(k) No: K000662
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510(k) Statement |
SE Decision Made: 04/03/2000 |
Attn: P. ARMSTRONG |
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PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E |
RD MEDICAL MFG., INC. |
BO. FULLADOSA |
CULEBRA PR 00775 |
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510(k) No: K001102
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510(k) Summary |
SE Decision Made: 04/20/2000 |
Attn: CARLOS A RODRIGUEZ-GARCIA |
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REDI-SCREEN |
REDWOOD BIOTECH, INC. |
1206 SESAME DR. |
SUNNYVALE CA 94087 |
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LIGHT BOND (QUICK CURE) |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
1100 W. IRVING PARK RD. |
SCHAUMBURG IL 60193 |
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510(k) No: K001048
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510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: KATHRYN B PATTERSON |
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LIFECARD CF COMPACT RECORDER |
REYNOLDS MEDICAL LTD. |
377 RT. 17 S. |
HASBROUCK HEIGHTS NJ 07604 |
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510(k) No: K001025
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510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: GEORGE MYERS |
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RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE |
RHINOMETRICS A/S |
555 13TH ST. N.W. |
WASHINGTON DC 20004 -110 |
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510(k) No: K000406
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510(k) Summary |
SE Decision Made: 04/17/2000 |
Attn: HOWARD M HOLSTEIN |
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ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. P.O. BOX 50457 |
INDIANAPOLIS IN 46250 -045 |
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ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. P.O. BOX 50457 |
INDIANAPOLIS IN 46250 -045 |
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ELECSYS THYROGLOBULIN CALCHECK |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. P.O. BOX 50457 |
INDIANAPOLIS IN 46250 -045 |
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510(k) No: K001015
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510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: KAY A TAYLOR |
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ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. P.O. BOX 50457 |
INDIANAPOLIS IN 46250 -045 |
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510(k) No: K000096
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510(k) Summary |
SE Decision Made: 04/26/2000 |
Attn: JENNIFER TRIBBETT |
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COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. P.O. BOX 50457 |
INDIANAPOLIS IN 46250 -045 |
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510(k) No: K000534
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: KAY A TAYLOR |
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HYSTALOG HSG CATHETER |
ROCKET MEDICAL PLC |
WEAR IND. ESTATE DISTRICT 6 |
WASHINGTON, TYNE & WEAR NE37 1NE |
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510(k) No: K000340
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510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: L. TODD |
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EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES |
ROCKET MEDICAL PLC |
WARE INDUSTRIAL ESTATE |
WASHINGTON, TYNE & WEAR NE37 1NE |
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510(k) No: K000205
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510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: LES TODD |
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SUNI MAX |
SATELEC |
70 WALNUT ST. |
WELLESLEY MA 02481 |
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510(k) No: K000049
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510(k) Summary |
SE Decision Made: 04/04/2000 |
Attn: JACQUELINE E MASSE |
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VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
SGMP CO., LTD. |
198 AVENUE DE LA D'EMERALD |
SPARKS NV 89434 |
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510(k) No: K000390
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: JANNA P TUCKER |
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VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
SGMP CO., LTD. |
198 AVENUE DE LA D'EMERALD |
SPARKS NV 89434 |
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510(k) No: K000391
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: JANNA P TUCKER |
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POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR |
SGMP CO., LTD. |
181 MOO 6, TAMBOL KAMPAENGPETCH, RATTAPHUM |
SONGKHLA 90180 |
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510(k) No: K000867
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: CHEAH CHOR HEE |
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NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES |
SGMP CO., LTD. |
181 MOO 6, TAMBOL KAMPAENGPETCH, RATTAPHUM |
SONGKHLA 90180 |
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510(k) No: K000868
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510(k) Summary |
SE Decision Made: 04/20/2000 |
Attn: CHEAH CHOR HEE |
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DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
259 YUSHU RD., CANGQIAO TOWNSHIP |
SONGJIANG SHANGHAI |
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510(k) No: K000872
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510(k) Statement |
SE Decision Made: 04/05/2000 |
Attn: JOHN LAI |
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DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
259 YUSHU RD., CANGQIAO TOWNSHIP |
SONGJIANG SHANGHAI |
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510(k) No: K000953
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510(k) Statement |
SE Decision Made: 04/20/2000 |
Attn: JOHN LAI |
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NITRILE EXAM GLOVE, POWDER FREE, BLUE |
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. |
198 AVENUE DE D'EMERALD |
SPARKS NV 89434 |
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510(k) No: K000670
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: JANNA P TUCKER |
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POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. |
198 AVENUE DE D'EMERALD |
SPARKS NV 89434 |
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510(k) No: K000584
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510(k) Summary |
SE Decision Made: 04/12/2000 |
Attn: JANNA P TUCKER |
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SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 |
SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
DUNDEE DD2 1 SW |
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510(k) No: K000398
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510(k) Statement |
SE Decision Made: 04/17/2000 |
Attn: EILEEN MCCAFFERTY |
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NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
30798 US HWY 19 NORTH |
PALM HARBOR FL 34684 |
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510(k) No: K000323
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: JOY LANCASTER |
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NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
30798 US HWY 19 NORTH |
PALM HARBOR FL 34684 |
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510(k) No: K000329
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: JOY LANCASTER |
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NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
30798 US HWY 19 NORTH |
PALM HARBOR FL 34684 |
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510(k) No: K000330
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: JOY LANCASTER |
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ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. |
ST. LOUIS MO 63103 |
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510(k) No: K000527
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510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: WILLIAM R GILBERT |
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ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. |
ST. LOUIS MO 63103 |
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510(k) No: K000528
|
510(k) Summary |
SE Decision Made: 04/07/2000 |
Attn: WILLIAM R GILBERT |
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CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL MN 55112 |
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510(k) No: K000942
|
510(k) Summary |
SE Decision Made: 04/27/2000 |
Attn: LISA STONE |
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CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK |
SIMS PORTEX, INC. |
10 BOWMAN DR. |
KEENE NH 03431 |
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SONADA ULTRASOUND SYSTEM |
SONOVISION CORP. |
377 ROUTE 17 SOUTH SUITE 204 |
HASBROUCK HEIGHTS NJ 07604 |
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ESKA MODULAR HIP SYSTEM |
SPECS USA, INC. |
635 SOUTH ORANGE AVE. |
SARASOTA FL 34236 |
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CHILI VIDEO, CHILI VIDEOPRO |
STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK |
24 EASTMAN AVE. C5 |
BEDFORD NH 03110 |
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510(k) No: K000411
|
510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: JIM DOYLE |
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PROVEN KNEE SYSTEM |
STELKAST COMPANY |
800 VINIAL STREET, SUITE B-210 |
PITTSBURGH PA 15212 |
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510(k) No: K000113
|
510(k) Statement |
SE Decision Made: 04/04/2000 |
Attn: DONALD A STEVENS |
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STERLTECH WATER PURIFIER |
STERLTECH, INC. |
60 LAKESIDE BLVD. WEST |
WATERBURY CT 06708 |
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510(k) No: K000941
|
510(k) Statement |
SE Decision Made: 04/06/2000 |
Attn: JOHN R NOLL |
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PARA 12 PLUS RETICS |
STRECK LABORATORIES, INC. |
14124 INDUSTRIAL RD. |
OMAHA NE 68145 -062 |
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510(k) No: K000945
|
510(k) Summary |
SE Decision Made: 04/18/2000 |
Attn: PAUL KITTELSON |
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DEVILBISS NEBULIZER MODEL 800 |
SUNRISE MEDICAL HHG, INC. |
100 DEVILBISS DR. |
SOMERSET PA 15501 |
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LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM |
SURETEX PROPHYLACTICS LTD. |
1500 INDUSTRIAL RD. P.O. 1252 |
DOTHAN AL 36302 |
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510(k) No: K000408
|
510(k) Summary |
SE Decision Made: 04/19/2000 |
Attn: LON D MCINVAIN |
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|
KERR GEL ETCHANT |
SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. |
ORANGE CA 92867 |
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510(k) No: K000954
|
510(k) Summary |
SE Decision Made: 04/28/2000 |
Attn: ORLANDO TADEO, JR. |
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SYNTHES (USA) WRIST FUSION PLATES (WFP) |
SYNTHES (USA) |
1690 RUSSELL RD. POST OFFICE BOX 1766 |
PAOLI PA 19301 |
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510(k) No: K000558
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: SHERI L MUSGNUNG |
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SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM |
SYNTHES (USA) |
P.O. BOX 1766 1690 RUSSELL ROAD |
PAOLI PA 19301 -122 |
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TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O |
TEKMEDIC (M) SDN BHD |
6324 MEETING HOUSE WAY |
ALEXANDRIA VA 22312 -171 |
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510(k) No: K000555
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510(k) Statement |
SE Decision Made: 04/12/2000 |
Attn: KOK-KEE HON |
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TFX MEDICAL STYLET CATHETER |
TFX MEDICAL GROUP |
TALL PINES PARK |
JAFFREY NH 03452 |
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HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER |
THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD |
SANTA MONICA CA 90404 |
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510(k) No: K000701
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510(k) Statement |
SE Decision Made: 04/27/2000 |
Attn: JAY H GELLER |
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OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
280 UTAH AVE. |
SOUTH SAN FRANCISCO CA 94080 -688 |
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510(k) No: K000549
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510(k) Summary |
SE Decision Made: 04/20/2000 |
Attn: KEN NEHMER |
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UM-L25 |
UNION MEDICAL ENGENEERING CO., LTD. |
1200 N.W. 78TH ST. SUITE 110 |
MIAMI FL 33126 |
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510(k) No: K000222
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510(k) Statement |
SE Decision Made: 04/19/2000 |
Attn: ANNIE VELEZ |
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DIGITAL INFLECTION RIGIDOMETER (DIR) |
UROAN XXI ELECTROMEDICINA |
C/ ANSELM TURMEDA, 12 PALMA DE MALLORCA |
BALEARES 07003 |
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510(k) No: K000194
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510(k) Summary |
SE Decision Made: 04/10/2000 |
Attn: VICTORIA GAYA |
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CAVERMAP SURGICAL AID |
UROMED CORP. |
1400 PROVIDENCE HWY. |
NORWOOD MA 02062 |
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510(k) No: K000507
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510(k) Summary |
SE Decision Made: 04/21/2000 |
Attn: FREDERICK TOBIA |
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EROS-CLITORAL THERAPY DEVICE (CTD) |
UROMETRICS, INC. |
445 ETNA ST., SUITE 56 |
ST. PAUL MN 55106 |
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510(k) No: DEN000006
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SE Decision Made: 04/28/2000 |
Attn: PHILIP A MESSINA |
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INTERVENTIONAL BODY COIL |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA OH 44202 |
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510(k) No: K000437
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: RONY THOMAS |
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LEMAITRE OCCLUSION CATHETER |
VASCUTECH, INC. |
164 MIDDLESEX TURNPIKE |
BURLINGTON MA 01803 |
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VISION R/F TILTING TABLE |
VILLA SISTEMI MEDICALI S.P.A. |
11550 WEST KING ST. |
FRANKLIN PARK IL 60131 |
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510(k) No: K000412
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510(k) Statement |
SE Decision Made: 04/24/2000 |
Attn: JEFFERY N MOELLER |
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BODYGUARD |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA NJ 07512 |
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510(k) No: K000441
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510(k) Summary |
SE Decision Made: 04/11/2000 |
Attn: ANTHONY MARTINO |
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MEDVIZER PACS, MODEL RELEASE 2000 |
VITEL NET |
8201 GREENSBORO DR. SUITE 820 |
MCLEAN VA 22102 |
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510(k) No: K000557
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510(k) Summary |
SE Decision Made: 04/24/2000 |
Attn: ALLEN IZADPANAH |
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WAKO L-TYPE UN TEST |
WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD |
RICHMOND VA 23237 |
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WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR |
WALLACH SURGICAL DEVICES, INC. |
235 EDISON RD. |
ORANGE CT 06477 |
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510(k) No: K000768
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510(k) Statement |
SE Decision Made: 04/11/2000 |
Attn: MICHAEL MALIS |
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ACTICOAT FOAM DRESSING |
WESTAIM BIOMEDICAL, INC. |
ONE HAMPTON RD. SUITE 302 |
EXETER NH 03833 |
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510(k) No: K000051
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510(k) Summary |
SE Decision Made: 04/05/2000 |
Attn: Steve Chartier |
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PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU |
SALAK TINGGI, SEPANG SELANGOR 43900 |
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510(k) No: K000971
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510(k) Summary |
SE Decision Made: 04/14/2000 |
Attn: YUE WAH CHOW |
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ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 |
ZCV ,INC. |
298 FERNWOOD AVE. |
EDISON NJ 08837 |
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510(k) No: K991060
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510(k) Summary |
SE Decision Made: 04/06/2000 |
Attn: PRISCILLA WHITEHEAD COX |
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