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U.S. Department of Health and Human Services

510(k) Final Decisions Rendered for April 2000

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Return to Search 315 Records for Decision Date:  April 2000 , sorted by Applicant Name (A-Z)
INSUFFLATION NEEDLE, MODEL R65-933
A & A MEDICAL, INC.
9370 INDUSTRIAL TRACE
ALPHARETTA GA 30004 -338
510(k) No: K000027
510(k) Summary
SE Decision Made: 04/03/2000
Attn: JIHAD MANSOUR
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS CA 95035 
510(k) No: K993116
510(k) Statement
SE Decision Made: 04/12/2000
Attn: JERRY WANG
AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG FL 33710 -290
510(k) No: K000961
510(k) Summary
SE Decision Made: 04/19/2000
Attn: RICHARD A KOZLOFF
FIXATION STYLETS, MODELS 335-287 AND 335-288
ACCUFIX RESEARCH INSTITUTE
12503 E. EUCLID DR. # 20
ENGLEWOOD CO 80111 
510(k) No: K000366
510(k) Statement
SE Decision Made: 04/14/2000
Attn: MICHAEL J ANDREWS
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE CA 94085 
510(k) No: K000478
510(k) Summary
SE Decision Made: 04/19/2000
Attn: LUANNE NG
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
ACRYMED, INC.
12232 S.W. GARDEN PL.
PORTLAND OR 97223 
510(k) No: K991818
510(k) Summary
SE Decision Made: 04/17/2000
Attn: BRUCE GIBBINS
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
ADAC LABORATORIES
540 ALDER DR.
MILPITAS CA 95035 
510(k) No: K993923
510(k) Summary
SE Decision Made: 04/07/2000
Attn: JANICE E BROWN
SKYLIGHT IMAGING SYSTEM
ADAC LABORATORIES
540 ALDER DR.
MILPITAS CA 95035 
510(k) No: K000908
510(k) Summary
SE Decision Made: 04/05/2000
Attn: JANICE E BROWN
OIL FOR TISSUE CULTURE
ADVANCED REPRODUCTIVE TECHNOLOGIES
3722 AVENUE SAUSALITO
IRVINE CA 92606 
510(k) No: K991380
510(k) Statement
SE Decision Made: 04/19/2000
Attn: GREG HOLLAND
ABC CERVICAL PLATING SYSTEM
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO CA 94080 
510(k) No: K000486
510(k) Summary
SE Decision Made: 04/14/2000
Attn: LIA S JONES
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
AGILENT TECHNOLOGIES, GMBH
HERRENBERGERSTR. 130
BOEBLINGEN  71034 
510(k) No: K000822
510(k) Summary
SE Decision Made: 04/06/2000
Attn: EGON PFEIL
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER MA 01810 -109
510(k) No: K000854
510(k) Summary
SE Decision Made: 04/10/2000
Attn: DAVE OSBORN
RGP MULTI-PURPOSE SOLUTION ID 100136
ALCON LABORATORIES
6201 SOUTH FREEWAY R7-14
FORT WORTH TX 76134 -209
510(k) No: K000148
510(k) Summary
SE Decision Made: 04/11/2000
Attn: RALPH H LARSEN
OPTI-FREE EXPRESS LENS DROPS
ALCON UNIVERSAL, LTD.
6201 SOUTH FREEWAY
FORT WORTH TX 76134 -209
510(k) No: K000385
510(k) Summary
SE Decision Made: 04/28/2000
Attn: RALPH H LARSEN
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK IL 60085 
510(k) No: K993871
510(k) Summary
SE Decision Made: 04/21/2000
Attn: PATRICIA SHARPE-GREGG
MODIFICATION TO CONVERTORS SURGICAL GOWNS
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK IL 60085 
510(k) No: K001189
510(k) Summary
SE Decision Made: 04/21/2000
Attn: SHARON ROBBINS
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
ALPHATEC MFG., INC.
42-160 STATE ST.
PALM DESERT CA 92211 -514
510(k) No: K993513
510(k) Summary
SE Decision Made: 04/26/2000
Attn: JASON BLAIN
RAPIDONE- BENZODIAZEPINE TEST
AMERICAN BIO MEDICA CORP.
1001 G STREET, NW SUITE 500W
WASHINGTON DC 20001 
510(k) No: K992720
510(k) Summary
SE Decision Made: 04/03/2000
Attn: JOHN B DUBECK
RAPIDONE- BARBITURATE TEST
AMERICAN BIO MEDICA CORP.
1001 G STREET, NW SUITE 500W
WASHINGTON DC 20001 
510(k) No: K992451
510(k) Summary
SE Decision Made: 04/03/2000
Attn: JOHN B DUBECK
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
AMERIWATER
1257 STANLEY AVE.
DAYTON OH 45404 
510(k) No: K991519
510(k) Summary
SE Decision Made: 04/14/2000
Attn: SANDRA E MONSMAN
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET NY 11791 
510(k) No: K000537
510(k) Summary
SE Decision Made: 04/27/2000
Attn: RICHARD KUO
NYLON NONABSORBABLE SURGICAL SUTURES, USP
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET NY 11791 
510(k) No: K000539
510(k) Summary
SE Decision Made: 04/27/2000
Attn: RICHARD KUO
POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET NY 11791 
510(k) No: K000540
510(k) Summary
SE Decision Made: 04/27/2000
Attn: RICHARD KUO
SILK NONABSORBABLE SURGICAL SUTURES, USP
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET NY 11791 
510(k) No: K000541
510(k) Summary
SE Decision Made: 04/28/2000
Attn: RICHARD KUO
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET NY 11791 
510(k) No: K000542
510(k) Summary
SE Decision Made: 04/28/2000
Attn: RICHARD KUO
THERMOFLEX SYSTEM
ARGOMED, INC.
3800 GATEWAY CENTER BLVD.
MORRISVILLE NC 27560 
510(k) No: K000508
510(k) Summary
SE Decision Made: 04/18/2000
Attn: RICHARD B KLEIN
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
ARMKEL, LLC.
P.O. BOX 1001, HALF ACRE RD.
CRANBURY NJ 08512 
510(k) No: K000748
510(k) Summary
SE Decision Made: 04/06/2000
Attn: STEPHEN C KOLAKOWSKY
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
ASAHI IRYOKI CO. LTD
10 NEW KING ST. SUITE 106
WHITE PLAINS NY 10604 
510(k) No: K000740
510(k) Summary
SE Decision Made: 04/12/2000
Attn: MIKE PAWLUK
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
AUTOMATIC LIQUID PACKAGING, INC.
2200 LAKE SHORE DR.
WOODSTOCK IL 60098 
510(k) No: K000964
510(k) Summary
SE Decision Made: 04/25/2000
Attn: JOHN BRDA
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
AVID MEDICAL, INC.
9000 WESTMONT DR. STONEHOUSE COMMERCE PARK
TOANO VA 23168 
510(k) No: K000117
510(k) Statement
SE Decision Made: 04/13/2000
Attn: SEAN F SHEMANSKI
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
AXELGAARD MFG. CO., LTD.
329 WEST AVIATION RD.
FALLBROOK CA 92028 -322
510(k) No: K000206
510(k) Statement
SE Decision Made: 04/13/2000
Attn: DAN JEFFERY
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER NY 14609 -354
510(k) No: K000247
510(k) Summary
SE Decision Made: 04/20/2000
Attn: YVONNE MIDDLEFELL
BAYER ADVIA IMS SYSTEM
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN NY 10591 -509
510(k) No: K993867
510(k) Summary
SE Decision Made: 04/10/2000
Attn: GABRIEL J MURACA
BAYER PSA ASSAY
BAYER CORP.
63 NORTH ST.
MEDFIELD MA 02052 -168
510(k) No: K994221
510(k) Summary
SE Decision Made: 04/13/2000
Attn: William J Pignato
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
7 LOVETON CIRCLE
SPARKS MD 21152 -099
510(k) No: K000829
510(k) Summary
SE Decision Made: 04/13/2000
Attn: BRADFORD SPRING
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
7 LOVETON CIRCLE
SPARKS MD 21152 -099
510(k) No: K000762
510(k) Summary
SE Decision Made: 04/25/2000
Attn: BRADFORD SPRING
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104 BOX 8000
BREA CA 92822 -800
510(k) No: K000410
510(k) Summary
SE Decision Made: 04/10/2000
Attn: LUCINDA STOCKERT
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104 BOX 8000
BREA CA 92822 -800
510(k) No: K000494
510(k) Summary
SE Decision Made: 04/14/2000
Attn: GAIL LEFEBVRE
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY UT 84070 
510(k) No: K000235
510(k) Summary
SE Decision Made: 04/05/2000
Attn: LESLIE WOOD
PICO SMOKERLYZER, MODEL EC-50
BEDFONT SCIENTIFIC LTD.
BEDFONT HOUSE HOLYWELL LANE
UPCHURCH, KENT  ME9 7 HN
510(k) No: K000962
510(k) Statement
SE Decision Made: 04/20/2000
Attn: MARTIN FOXLEY
BETEL POWDER FREE LATEX EXAM GLOVES
BETELCARE SDN BHD
71/2 MILES, OFF JALAN KAPAR KAPAR
SELANGOR DARUL EHSAN  42200 
510(k) No: K000650
510(k) Statement
SE Decision Made: 04/20/2000
Attn: K.B. SIAH
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 
510(k) No: K000652
510(k) Statement
SE Decision Made: 04/10/2000
Attn: KENG BENG SIAH
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
BIO-RAD
9500 JERONIMO RD.
IRVINE CA 92618 -201
510(k) No: K000874
510(k) Summary
SE Decision Made: 04/18/2000
Attn: ELIZABETH PLATT
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
BIO-RAD
9500 JERONIMO RD.
IRVINE CA 92618 -201
510(k) No: K000875
510(k) Summary
SE Decision Made: 04/20/2000
Attn: ELIZABETH PLATT
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
BIO-RAD
9500 JERONIMO RD.
IRVINE CA 92618 -201
510(k) No: K992781
510(k) Statement
SE Decision Made: 04/05/2000
Attn: ELIZABETH PLATT
LAZERSMILE, LAZERWHITE
BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN CLEMENTE CA 92673 
510(k) No: K000290
510(k) Summary
SE Decision Made: 04/14/2000
Attn: IOANA M RIZOIU
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 
510(k) No: K000299
510(k) Statement
SE Decision Made: 04/28/2000
Attn: JAMES L THOMPSON
BOHN FEMORAL COMPONENT
BIOMET MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK P.O. BOX 587
WARSAW IN 46581 -058
510(k) No: K000262
510(k) Summary
SE Decision Made: 04/03/2000
Attn: TINA LAKIN
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
510(k) No: K990830
510(k) Summary
SE Decision Made: 04/11/2000
Attn: PATRICIA SANDBORN BERES
PEDIATRIC FIXATION RODS
BIOMET, INC.
P.O. BOX 587 AIRPORT INDUSTRIAL PARK
WARSAW IN 46581 -058
510(k) No: K000764
510(k) Summary
SE Decision Made: 04/06/2000
Attn: PATRICIA SANDBORN BERES
ASCENT KNEE REVISION FEMORAL STEM
BIOMET, INC.
AIRPORT INDUSTRIAL PARK, P.O.BOX 587
WARSAW IN 46581 -058
510(k) No: K001010
510(k) Summary
SE Decision Made: 04/27/2000
Attn: TINA LAKIN
EMBOSPHERE MICROSPHERES
BIOSPHERE MEDICAL
1050 HINGHAM ST.
ROCKLAND MA 02370 
510(k) No: K991549
510(k) Summary
SE Decision Made: 04/26/2000
Attn: SHEILA HEMEON-HEYER
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 
510(k) No: K000763
510(k) Summary
SE Decision Made: 04/06/2000
Attn: Jon Brumbaugh
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 
510(k) No: K994240
510(k) Summary
SE Decision Made: 04/13/2000
Attn: Jon Brumbaugh
VIP- VARIABLE INTENSITY POLYMERIZER
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG IL 60193 
510(k) No: K000426
510(k) Summary
SE Decision Made: 04/12/2000
Attn: KATHRYN B PATTERSON
RENEGADE HI-FLO MICROCATHETER
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick MA 01760 
510(k) No: K000177
510(k) Summary
SE Decision Made: 04/07/2000
Attn: TERRY A MCGOVERN
TRANSLUMINAL BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK MA 01760 -153
510(k) No: K993305
510(k) Summary
SE Decision Made: 04/10/2000
Attn: TERRY A MCGOVERN
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 
510(k) No: K000570
510(k) Summary
SE Decision Made: 04/13/2000
Attn: TERRY A MCGOVERN
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE MN 55311 
510(k) No: K000956
510(k) Summary
SE Decision Made: 04/21/2000
Attn: MELANIE RASKA
JET PORT PLUS CATHETER SYSTEM
CLINICAL PLASTIC PRODUCTS SA
154 VIA LAMPARA
RANCHO SANTA MARGARITA CA 92688 
510(k) No: K000125
510(k) Summary
SE Decision Made: 04/12/2000
Attn: SALVADORE F PALOMARES
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA CO 80004 
510(k) No: K000255
510(k) Summary
SE Decision Made: 04/25/2000
Attn: LYNNE LEONARD
TENAX WHITE POST
COLTENE/WHALEDENT INC.
750 CORPORATE DR.
MAHWAH NJ 07430 -200
510(k) No: K993545
510(k) Statement
SE Decision Made: 04/14/2000
Attn: H.J. VOGELSTEIN
CTC DVT-1 CALF GARMENT, MODEL DVT-1
COMPRESSION THERAPY CONCEPTS, INC.
3614 KENNEDY RD.
SOUTH PLAINFIELD NJ 07080 
510(k) No: K000147
510(k) Statement
SE Decision Made: 04/13/2000
Attn: J. JAMES BRITTON
ENHANCED COMPENSATING FILTER
COMPUTERIZED MEDICAL SYSTEMS, INC.
1195 CORPORATE LAKE DR.
ST. LOUIS MO 63132 -171
510(k) No: K000137
510(k) Summary
SE Decision Made: 04/17/2000
Attn: MICHAEL A PARSONS
QUALITROL LIPID CONTROL, LEVELS 1 AND 2
CONSOLIDATED TECHNOLOGIES OF WISCONSIN
2170 WOODWARD ST.
AUSTIN TX 78744 -183
510(k) No: K000810
510(k) Statement
SE Decision Made: 04/13/2000
Attn: RUSTY SEWELL
CSM STRETTA SYSTEM
CONWAY STUART MEDICAL, INC.
555 THIRTEENTH ST. N.W.
WASHINGTON DC 20004 -110
510(k) No: K000245
510(k) Summary
SE Decision Made: 04/18/2000
Attn: JONATHAN S KAHAN
CORDIS INTRODUCER GUIDE
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES FL 33014 
510(k) No: K001136
510(k) Summary
SE Decision Made: 04/28/2000
Attn: ARIEL MACTAVISH
CORDIS 13F CATHETER SHEATH INTRODUCER
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES FL 33014 
510(k) No: K000753
510(k) Summary
SE Decision Made: 04/06/2000
Attn: ARIEL MACTAVISH
AGILITY STEERABLE GUIDEWIRE
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES FL 33014 
510(k) No: K001033
510(k) Summary
SE Decision Made: 04/14/2000
Attn: MARITZA CELAYA
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
CORGENIX, INC.
12061 TEJON ST.
WESTMINSTER CO 80234 
510(k) No: K000920
510(k) Summary
SE Decision Made: 04/26/2000
Attn: NANCI DEXTER
CORTEK ARTHROSCOPE
CORTEK ENDOSCOPY, INC.
501 W. COLFAX, SUITE B
PALATINE IL 60067 
510(k) No: K000198
510(k) Summary
SE Decision Made: 04/11/2000
Attn: CORNEL M TOPALA
CORTEK MINI LAPAROSCOPE
CORTEK ENDOSCOPY, INC.
501 W. COLFAX, SUITE B
PALATINE IL 60067 
510(k) No: K000199
510(k) Statement
SE Decision Made: 04/13/2000
Attn: CORNEL M TOPALA
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
COULTER CORP.
11800 S.W. 147TH AVE. MAIL CODE 31-B06
MIAMI FL 33196 -250
510(k) No: K993356
510(k) Summary
SE Decision Made: 04/20/2000
Attn: STAN SUGRUE
8100 VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.
20925 CROSSROADS CIRCLE
WAUKESHA WI 53186 
510(k) No: K001020
510(k) Summary
SE Decision Made: 04/28/2000
Attn: ALEX KAPLAN
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
CRYSTAL REFLECTIONS, INT., INC.
1325 PROGRESS DR.
FRONT ROYAL VA 22630 
510(k) No: K993489
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JACK CARTER
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
DADE BEHRING, INC.
7739 NW 48 ST. SUITE 120
MIAMI FL 33166 
510(k) No: K000649
510(k) Summary
SE Decision Made: 04/25/2000
Attn: RADAMES RIESGO
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000458
510(k) Summary
SE Decision Made: 04/17/2000
Attn: JUDY MCINNIS-BERGER
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000459
510(k) Summary
SE Decision Made: 04/03/2000
Attn: JUDY MCINNIS-BERGER
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000460
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JUDY MCINNIS-BERGER
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000461
510(k) Summary
SE Decision Made: 04/06/2000
Attn: JUDY MCINNIS-BERGER
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000462
510(k) Summary
SE Decision Made: 04/06/2000
Attn: JUDY MCINNIS-BERGER
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000464
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JUDY MCINNIS-BERGER
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000466
510(k) Summary
SE Decision Made: 04/05/2000
Attn: JUDY MCINNIS-BERGER
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK DE 19714 
510(k) No: K000467
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JUDY MCINNIS-BERGER
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
DATEX-OHMEDA
THREE HIGHWOOD DR.
TEWKSBURY MA 01876 
510(k) No: K000168
510(k) Summary
SE Decision Made: 04/13/2000
Attn: JOEL KENT
DATES-OHMEDA AESTIVA SMARTVENT MRI
DATEX-OHMEDA, INC.
OHMEDA DR. P.O. BOX 7550
MADISON WI 53707 -755
510(k) No: K993410
510(k) Summary
SE Decision Made: 04/25/2000
Attn: DANIEL KOSEDNAR
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
510(k) No: K000275
510(k) Summary
SE Decision Made: 04/12/2000
Attn: DANIEL KOSEDNAR
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
DATEX-OHMEDA, INC.
3 HIGHWOOD DR.
TEWKSBURY MA 01876 
510(k) No: K993608
510(k) Statement
SE Decision Made: 04/13/2000
Attn: JOEL C KENT
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
DENTSPLY INTL.
901 WEST OAKTON ST.
DES PLAINES IL 60018 -188
510(k) No: K000112
510(k) Summary
SE Decision Made: 04/13/2000
Attn: WILLIAM T COUSINS
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM MA 02767 -035
510(k) No: K001105
510(k) Summary
SE Decision Made: 04/24/2000
Attn: LISA GILMAN
RESPONSE 2000 HIP STEM
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW IN 46581 -098
510(k) No: K000392
510(k) Summary
SE Decision Made: 04/24/2000
Attn: ARLENE C SAULL
RESPONSE 2000 CEMENTED HIP STEM
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW IN 46581 -098
510(k) No: K000432
510(k) Summary
SE Decision Made: 04/24/2000
Attn: ARLENE C SAULL
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
DIASORIN, INC.
4029 CHARIOT'S FLIGHT WAY
ELLICOTT CITY MD 21042 
510(k) No: K001118
510(k) Summary
SE Decision Made: 04/25/2000
Attn: JUDITH J SMITH
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
510(k) No: K001021
510(k) Summary
SE Decision Made: 04/25/2000
Attn: BARRY SALL
HONIGUM
DMG USA, INC.
5 WHITCOMB AVE.
AYER MA 01432 
510(k) No: K000878
510(k) Summary
SE Decision Made: 04/11/2000
Attn: PAMELA PAPINEAU
LUXAFORM
DMG USA, INC.
5 WHITCOMB AVE.
AYER MA 01432 
510(k) No: K000951
510(k) Summary
SE Decision Made: 04/05/2000
Attn: PAMELA PAPINEAU
IQ CHAMBERS
DORMER LABORATORIES, INC.
2000 M. ST., N.W., 7TH FLOOR
WASHINGTON DC 20036 -330
510(k) No: K992553
510(k) Summary
SE Decision Made: 04/12/2000
Attn: DANIEL MANELLI
DRG AURICA ELISA TESTOSTERONE KIT
DRG INTL., INC.
150 CHERRY LANE RD.
EAST STROUDSBURG PA 18301 
510(k) No: K000043
510(k) Summary
SE Decision Made: 04/17/2000
Attn: NIKOLAS BUTKOV
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000400
510(k) Summary
SE Decision Made: 04/18/2000
Attn: PATRICK BEENTJEES
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000402
510(k) Summary
SE Decision Made: 04/18/2000
Attn: PATRICK BEENTJES
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000350
510(k) Summary
SE Decision Made: 04/11/2000
Attn: PATRICK BEENTJES
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000273
510(k) Summary
SE Decision Made: 04/07/2000
Attn: PATRICK BEENTJES
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000449
510(k) Summary
SE Decision Made: 04/07/2000
Attn: PATRICK BEENTJES
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000452
510(k) Summary
SE Decision Made: 04/24/2000
Attn: PATRICK BEENTJES
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT SUITE A-7
ALPHARETTA GA 30005 
510(k) No: K000522
510(k) Summary
SE Decision Made: 04/18/2000
Attn: PATRICK BEENTJES
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO  M1S 3 S4
510(k) No: K992732
510(k) Statement
SE Decision Made: 04/20/2000
Attn: SAM LAKHANI
MODIFICATION TO EBI SPINELINK SYSTEM
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY NJ 07054 
510(k) No: K001037
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JONAS WILF
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 
510(k) No: K000029
510(k) Summary
SE Decision Made: 04/04/2000
Attn: CATHERINE G GOBLE
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 
510(k) No: K993448
510(k) Summary
SE Decision Made: 04/10/2000
Attn: CATHERINE G GOBLE
VIEW NT
ELECTROMED INTL., LTD.
310 INDUSTRIAL BLVD.
ST-EUSTACHE, QUEBEC  J7R 5 R4
510(k) No: K000474
510(k) Summary
SE Decision Made: 04/19/2000
Attn: PASCAL M KAUFMANN
BIOLOK SCREW
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN TX 78758 
510(k) No: K993630
510(k) Summary
SE Decision Made: 04/26/2000
Attn: DEBBIE DE LOS SANTOS
INCENTIVE SPIROMETER
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS IN 46241 
510(k) No: K000314
510(k) Summary
SE Decision Made: 04/12/2000
Attn: BONNIE HOLLY
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
ENTERIC MEDICAL TECHNOLOGIES
1125 EAST HILLSDALE BLVD. SUITE 106
FOSTER CITY CA 94404 
510(k) No: K000646
510(k) Statement
SE Decision Made: 04/13/2000
Attn: JILL M VISOR
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
ERCHINGER MEDIZINTECNIK
AMSTEL 320 I
AMSTERDAM  1017  AP
510(k) No: K000297
510(k) Summary
SE Decision Made: 04/24/2000
Attn: DAGMAR MASER
DIMENSION PENTA L
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA  D-822 29
510(k) No: K000595
510(k) Summary
SE Decision Made: 04/05/2000
Attn: ANDREAS PETERMANN
EVERSHEARS BIPOLAR SCISSORS
EVEREST MEDICAL CORP.
13755 FIRST AVENUE, NORTH, SUITE 500
MINNEAPOLIS MN 55441 -544
510(k) No: K000496
510(k) Summary
SE Decision Made: 04/24/2000
Attn: FREDERICK G MADES
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
510(k) No: K994099
510(k) Summary
SE Decision Made: 04/12/2000
Attn: DOREEN FENG
EEG WITH VIDEO, MODEL EX-NW
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO  L6H  5S1
510(k) No: K000898
510(k) Summary
SE Decision Made: 04/14/2000
Attn: DEBBIE DAVY
BIOCERAMIC ORBITAL IMPLANT
FCI OPHTHALMICS, INC.
P.O. BOX 465 76 PROSPECT ST.
MARSHFIELD HILLS MA 02051 
510(k) No: K992294
510(k) Statement
SE Decision Made: 04/19/2000
Attn: ANNE BOHSACK
PACSSTATION
FERNANDEZ INDUSTRIES, INC.
35 VINE ST. # 204
WINCHESTER MA 01890 
510(k) No: K000448
510(k) Summary
SE Decision Made: 04/20/2000
Attn: ANTHONY FERNANDEZ
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
510(k) No: K001216
510(k) Statement
SE Decision Made: 04/28/2000
Attn: JOSEPH J E PEREIRA
STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
FITCO DIPPED PRODUCTS PVT. LTD
14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, KOCHIN
KERALA  682 0 30
510(k) No: K000891
510(k) Statement
SE Decision Made: 04/28/2000
Attn: JOSEPH J E PEREIRA
LORAD LT-100 LASER TREATMENT SYSTEM
FOCUS MEDICAL, LLC.
39 SILVER SPRING PARK
RIDGEFIELD CT 06877 
510(k) No: K992597
510(k) Summary
SE Decision Made: 04/24/2000
Attn: JOHN LEE
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
FOTONA D.D.
STEGNE 7,
LJUBLJANA  1210 
510(k) No: K000106
510(k) Summary
SE Decision Made: 04/18/2000
Attn: MOJCA VALJAVEC
FRIALIT-2 MH-2 ABUTMENT
FRIADENT GMBH
21911 ERIE LN.
LAKE FOREST CA 92630 
510(k) No: K994174
510(k) Summary
SE Decision Made: 04/20/2000
Attn: CAROL PATTERSON
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND WA 98052 -491
510(k) No: K000746
510(k) Summary
SE Decision Made: 04/07/2000
Attn: DAVID J GERAGHTY
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
FUTURE DIAGNOSTICS B.V.
4079 MT. BARNARD
SAN DIEGO CA 92111 
510(k) No: K000471
510(k) Statement
SE Decision Made: 04/11/2000
Attn: DAVE D SMITH
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 
510(k) No: K000221
510(k) Summary
SE Decision Made: 04/11/2000
Attn: TED L PARROT
GE LOGIQ 700
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE WI 53188 
510(k) No: K000571
510(k) Summary
SE Decision Made: 04/18/2000
Attn: ALLEN SCHUH
GE LOGIQ 700
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE WI 53188 
510(k) No: K001016
510(k) Summary
SE Decision Made: 04/24/2000
Attn: ALLEN SCHUH
GE LOGIQ 700
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE WI 53201 
510(k) No: K000516
510(k) Summary
SE Decision Made: 04/19/2000
Attn: ALLEN SCHUH
GETTIG GUARD
GETTIG PHARMACEUTICAL INSTRUMENT CO.
55 Northern Blvd. Suite 200
Great Neck NY 11021 
510(k) No: K000455
510(k) Summary
SE Decision Made: 04/19/2000
Attn: JAMES A BENZ
GT990402 DIGITAL THERMOMETER
GLOBAL TREASURE LTD.
BLOCK2, 5/F,. ROOM 8 NAN FUNG IND. CITY
18 TIN HAU ROAD, TUEN MUN N.T.   
510(k) No: K001279
510(k) Summary
SE Decision Made: 04/28/2000
Attn: BEN MA
GSI 2000 MIDDLE EAR ANALYZER
GRASON-STADLER, INC.
1 WESTCHESTER DR.
MILFORD NH 03055 -305
510(k) No: K000097
510(k) Summary
SE Decision Made: 04/12/2000
Attn: NORMAN L SCHULTZ
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA CA 92591 -463
510(k) No: K000793
510(k) Summary
SE Decision Made: 04/12/2000
Attn: BYRON LAMBERT
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
55 NORTHERN BLVD., SUITE 200
GREAT NECK NY 11021 
510(k) No: K001047
510(k) Statement
SE Decision Made: 04/28/2000
Attn: SUSAN D GOLDSTEIN-FALK
WEHRS INCUS-STAPES
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT TN 38133 
510(k) No: K000858
510(k) Summary
SE Decision Made: 04/03/2000
Attn: ALICIA FARAGE
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF  CF3 0 LT
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 
510(k) No: K994023
510(k) Summary
SE Decision Made: 04/25/2000
Attn: ELAINE WHITMORE
HARDYDISK CEFTRIAXONE 30MCG
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA CA 93455 
510(k) No: K000440
510(k) Statement
SE Decision Made: 04/07/2000
Attn: MELISSA M TRAYLOR
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA CA 93455 
510(k) No: K000261
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 
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 
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 
510(k) No: K000272
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 
510(k) No: K000526
510(k) Statement
SE Decision Made: 04/13/2000
Attn: MELISSA M TRAYLOR
HARDYDISK, VANCOMYCIN 30MCG
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA CA 93455 
510(k) No: K000509
510(k) Statement
SE Decision Made: 04/07/2000
Attn: MELISSA M TRAYLOR
HARDYDISK, CEFOTAXIME 30MCG
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA CA 93455 
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 
510(k) No: K000525
510(k) Statement
SE Decision Made: 04/07/2000
Attn: MELISSA M TRAYLOR
ACTIVATOR PASTE
HARRY J. BOSWORTH CO.
7227 NORTH HAMLIN AVE.
SKOKIE IL 60076 
510(k) No: K994027
510(k) Statement
SE Decision Made: 04/13/2000
Attn: MILDRED M GOLDSTEIN
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM  1017  AP
510(k) No: K001123
510(k) Summary
SE Decision Made: 04/21/2000
Attn: DAGMAR S MASER
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM  1017  AP
510(k) No: K000127
510(k) Summary
SE Decision Made: 04/12/2000
Attn: DAGMAR MASER
SPIFE CHOLESTEROL PROFILE KIT
HELENA LABORATORIES
1530 LINDBERGH DR. P.O. BOX 752
BEAUMONT TX 77704 
510(k) No: K000603
510(k) Statement
SE Decision Made: 04/17/2000
Attn: ERIC PETERSEN
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
HELIX DIAGNOSTICS, INC.
3148 INDUSTRIAL BLVD.
WEST SACRAMENTO CA 95691 -622
510(k) No: K000489
510(k) Statement
SE Decision Made: 04/05/2000
Attn: VIRGINIA CAPPEL
FLEXTIME
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND IN 46614 -251
510(k) No: K000629
510(k) Statement
SE Decision Made: 04/05/2000
Attn: CHERYL V ZIMMERMAN
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO PA 19040 
510(k) No: K001019
510(k) Summary
SE Decision Made: 04/27/2000
Attn: JAMES G CARPENTER
HMS NEUROMUSCULAR STIMULATOR
HOME MEDICAL SERVICES, INC.
9393 ACTIVITY RD. SUITE F
SAN DIEGO CA 92126 
510(k) No: K994062
510(k) Statement
SE Decision Made: 04/10/2000
Attn: C.A. TEKLINSKI
MS-ONE, MODEL MS-1
HOME WELLNESS WEST
9393 ACTIVITY RD. SUITE F
SAN DIEGO CA 92126 
510(k) No: K994065
510(k) Statement
SE Decision Made: 04/04/2000
Attn: RICHARD M HARRIS
ASNIS III CANNULATED SCREW SYSTEM
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE NJ 07401 -167
510(k) No: K000080
510(k) Summary
SE Decision Made: 04/03/2000
Attn: MARY-CATHERINE DILLON
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 
510(k) No: K000725
510(k) Statement
SE Decision Made: 04/05/2000
Attn: K. KARUNAKARAN
LIGA-LOOP SUTURE APPLICATOR
HYSTERX, INC.
18732 SAGINAW
IRVINE CA 92612 
510(k) No: K993695
510(k) Summary
SE Decision Made: 04/13/2000
Attn: JUDY F GORDON
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
HYSTERX, INC.
18732 SAGINAW
IRVINE CA 92612 
510(k) No: K000911
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JUDY F GORDON
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
I-STAT CORP.
104 WINDSOR CENTER DR.
EAST WINDSOR NJ 08520 
510(k) No: K001154
510(k) Summary
SE Decision Made: 04/18/2000
Attn: PAUL VANDERWERF
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
IDEMSA
1600 STEWART AVE.
WESTBURY NY 11590 
510(k) No: K991908
510(k) Summary
SE Decision Made: 04/17/2000
Attn: LEON LACHMAN
CRANIAL DRILL
IMAGE-GUIDED NEUROLOGICS, INC.
2290 W. EAU GALLIE BLVD. SUITE 210
MELBOURNE FL 32935 
510(k) No: K000195
510(k) Statement
SE Decision Made: 04/20/2000
Attn: DAVID M LEE
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
INRAD
3956 44TH ST., S.E.
KENTWOOD MI 49512 
510(k) No: K000612
510(k) Summary
SE Decision Made: 04/24/2000
Attn: JOSEPH M MAZUREK
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
INTEGRATED ORBITAL IMPLANTS, INC.
4329 GRAYDON RD.
SAN DIEGO CA 92130 
510(k) No: K000151
510(k) Summary
SE Decision Made: 04/10/2000
Attn: FLOYD G LARSON
HAIDER-UCR SPINAL SYSTEM
INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC.
200 GREGORY LN. SUITE C-100
PLEASANT HILL CA 94523 
510(k) No: K993503
510(k) Summary
SE Decision Made: 04/14/2000
Attn: DAVID W SCHLERF
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE CA 92618 -240
510(k) No: K000876
510(k) Summary
SE Decision Made: 04/18/2000
Attn: LYNN M RODARTI
939UDX URINE PATHOLOGY SYSTEM
INTL. REMOTE IMAGING SYSTEMS
9162 ETON AVE.
CHATSWORTH CA 91311 
510(k) No: K000373
510(k) Summary
SE Decision Made: 04/14/2000
Attn: HARVEY L KASDAN
INTRASTENT DOUBLESTRUT XS STENT
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL MN 55112 
510(k) No: K000864
510(k) Summary
SE Decision Made: 04/14/2000
Attn: MARIA E BRITTLE
SUTUREGROOVE
IOP, INC.
3151 AIRWAY AVE., BLDG. I-1
COSTA MESA CA 92626 
510(k) No: K994289
510(k) Statement
SE Decision Made: 04/17/2000
Attn: JASON MALECKA
SAMPLOK
ITL CORPORATION, PTY LTD.
15825 SHADY GROVE RD. SUITE 90
ROCKVILLE MD 20850 
510(k) No: K000777
510(k) Statement
SE Decision Made: 04/11/2000
Attn: KENNETH A PALMER
JELDENT BASIC LINE
J.F. JELENKO & CO.
99 BUSINESS PARK DR.
ARMONK NY 10504 
510(k) No: K000213
510(k) Statement
SE Decision Made: 04/06/2000
Attn: RAPHAEL JUDKINS
JEL 15
J.F. JELENKO & CO., INC.
99 BUSINESS PARK DR.
ARMONK NY 10504 
510(k) No: K000532
510(k) Statement
SE Decision Made: 04/06/2000
Attn: RAPHAEL JUDKINS
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
JB STAR SDN BHD
3A JALAN CEKOR, TAMAN SRI AMAR
JOHOR BARUE, JOHOR  81100 
510(k) No: K001094
510(k) Statement
SE Decision Made: 04/28/2000
Attn: LOOI CHIN SWEE
RX EVEREST
JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724
WALLINGFORD CT 06492 -072
510(k) No: K001051
510(k) Summary
SE Decision Made: 04/28/2000
Attn: ANNMARIE TENERO
MODIFICATION TO JMS APHERESIS NEEDLE
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA  730-8 652
510(k) No: K000843
510(k) Statement
SE Decision Made: 04/10/2000
Attn: KEISUKE URATOMI
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA  730-8 652
510(k) No: K000845
510(k) Statement
SE Decision Made: 04/10/2000
Attn: KEISUKE URATOMI
SIPHONGUARD CSF CONTROL DEVICE
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM MA 02767 -035
510(k) No: K992173
510(k) Summary
SE Decision Made: 04/07/2000
Attn: LAURA O'GRADY
K-ASSAY AT-III
KAMIYA BIOMEDICAL CO.
910 INDUSTRY DR.
SEATTLE WA 98188 -341
510(k) No: K000361
510(k) Statement
SE Decision Made: 04/26/2000
Attn: COLIN GETTY
KSEA CHARDONNES MORCELLATION KNIFE
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY CA 90230 -760
510(k) No: K000212
510(k) Summary
SE Decision Made: 04/21/2000
Attn: KEVIN KENNAN
EZ CONNECT
KERR DENTAL MATERIALS CENTER
1717 WEST COLLINS AVE.
ORANGE CA 92867 
510(k) No: K000346
510(k) Summary
SE Decision Made: 04/14/2000
Attn: COLLEEN BOSWELL
EZ CONNECT RESIN
KERR DENTAL MATERIALS CENTER
1717 WEST COLLINS AVE.
ORANGE CA 92867 
510(k) No: K000357
510(k) Summary
SE Decision Made: 04/28/2000
Attn: COLLEEN BOSWELL
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
LONDON INTERNATIONAL GROUP, INC.
P.O. BOX 8308 2926 COLUMBIA HIGHWAY
DOTHAN AL 36304 
510(k) No: K991677
510(k) Statement
SE Decision Made: 04/12/2000
Attn: BRADLEY L PUGH
PRODIGY LATERAL VIEW SOFTWARE
LUNAR CORP.
726 HEARTLAND TRAIL
MADISON WI 53717 
510(k) No: K000826
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JAMES P RASKOB
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
MALLINCKRODT DAR S.R.L.
VIA G.BOVE, 2/4/6/8
MIRANDOLA (MODENA)  41037 
510(k) No: K993268
510(k) Summary
SE Decision Made: 04/19/2000
Attn: GIUSEPPE TOMASINI
MEDISUL DISPOSABLE VAGINAL SPECULUM
MARKETING PERSPECTIVES
6565 146TH AVE.
HOLLAND MI 49423 
510(k) No: K000414
510(k) Summary
SE Decision Made: 04/04/2000
Attn: JIMMIE D WILSON
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
MARTIN URAM, MD
39 SYCAMORE AVE.
LITTLE SILVER NJ 07739 -120
510(k) No: K000192
510(k) Summary
SE Decision Made: 04/10/2000
Attn: MARTIN URAM
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
510(k) No: K000126
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JAMES J CRONIN
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
510(k) No: K000985
510(k) Statement
SE Decision Made: 04/24/2000
Attn: KOK-KEE HON
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
MATSUSHITA ELECTRIC CORP. OF AMERICA
1730 PENNSYLVANIA AVE., N.W.
WASHINGTON DC 20006 -470
510(k) No: K991458
510(k) Summary
SE Decision Made: 04/10/2000
Attn: EDWARD M BASILE
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO  K2K1X 8
510(k) No: K001006
510(k) Summary
SE Decision Made: 04/27/2000
Attn: E S MARTELL
WILSON-COOK COLONIC Z-STENT
MED INSTITUTE, INC.
1400 CUMBERLAND AVE. P.O. BOX 2402
WEST LAFAYETTE IN 47906 
510(k) No: K990034
510(k) Summary
SE Decision Made: 04/17/2000
Attn: NEAL E FEARNOT
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS MN 55447 
510(k) No: K000824
510(k) Statement
SE Decision Made: 04/13/2000
Attn: DENNIS MADISON
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE WI 53226 
510(k) No: K000345
510(k) Summary
SE Decision Made: 04/11/2000
Attn: THOMAS E TYNES
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE IL 60089 
510(k) No: K000712
510(k) Statement
SE Decision Made: 04/27/2000
Attn: JOEL ORLINSKY
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
MEDIONICS INTERNATIONAL, INC.
114 ANDERSON AVE.
MARKHAM, ONTARIO  L6E 1 A5
510(k) No: K993149
510(k) Statement
SE Decision Made: 04/28/2000
Attn: MASHESH AGARWAL
MEDLINE TENDER WET WOUND DRESSING
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN IL 60060 
510(k) No: K991755
510(k) Statement
SE Decision Made: 04/17/2000
Attn: LARA N SIMMONS
MEDTRADE PRODUCTS ALGINATE ISLAND
MEDTRADE PRODUCTS LTD.
ELECTRA HOUSE CREWE BUSINESS PARK
CREWE, CHESHIRE  CW1 6 GL
510(k) No: K000487
510(k) Statement
SE Decision Made: 04/18/2000
Attn: JONATHAN RANFIELD
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 WATSON S.W.
GRAND RAPIDS MI 49504 
510(k) No: K994171
510(k) Summary
SE Decision Made: 04/27/2000
Attn: JAMES BALUN
MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS TN 38132 
510(k) No: K000991
510(k) Summary
SE Decision Made: 04/18/2000
Attn: RICHARD W TREHARNE
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
MEDTRONIC VASCULAR
620 WATSON STRET S.W.
GRAND RAPIDS MI 49504 
510(k) No: K993677
510(k) Summary
SE Decision Made: 04/17/2000
Attn: MICHAEL HINGSON
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 
510(k) No: K000105
510(k) Summary
SE Decision Made: 04/12/2000
Attn: PAM SCHAUB
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
MEDTRONIC VASCULAR
4633 E. LA PALMA AVE.
ANAHEIM CA 92807 
510(k) No: K001138
510(k) Summary
SE Decision Made: 04/27/2000
Attn: MARIE HOLM
MEDTRONIC MODEL 7499 EXTENSION
MEDTRONIC VASCULAR
800 53RD AVENUE, NE P.O. BOX 1250
MINNEAPOLIS MN 55440 -908
510(k) No: K000445
510(k) Summary
SE Decision Made: 04/28/2000
Attn: Kathy Jo Fahey
MDI SCL-70 TEST
MICRO DETECT, INC.
2852 WALNUT AVE., SUITE H-1
TUSTIN CA 92780 -703
510(k) No: K000934
510(k) Summary
SE Decision Made: 04/07/2000
Attn: MEHDI ALEM
RENAFLO II HF 2000 HEMOFILTER
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS MN 55447 
510(k) No: K000028
510(k) Summary
SE Decision Made: 04/04/2000
Attn: RICHARD M ORMSBEE
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
MINXRAY, INC.
3611 COMMERCIAL AVE.
NORTHBROOK IL 60062 
510(k) No: K000061
510(k) Summary
SE Decision Made: 04/07/2000
Attn: KEITH KRETCHMER
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
MITEK PRODUCTS
60 GLACIER DR.
WESTWOOD MA 02090 
510(k) No: K000936
510(k) Summary
SE Decision Made: 04/19/2000
Attn: MARY P LEGRAW
KFA-63 KNEE AND FOOT ARRAY
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA WI 53186 
510(k) No: K000935
510(k) Statement
SE Decision Made: 04/07/2000
Attn: THOMAS SCHUBERT
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
MRL DIAGNOSTICS
10703 PROGRESS WAY
CYPRESS CA 90630 -473
510(k) No: K000238
510(k) Summary
SE Decision Made: 04/14/2000
Attn: MICHAEL J WAGNER
MTP DISPOSABLE TROCAR VALVES
MTP MEDICAL TECHNICAL PROMOTION GMBH
600 CORPORATE POINTE
CULVER CITY CA 90230 
510(k) No: K000337
510(k) Summary
SE Decision Made: 04/12/2000
Attn: KEVIN KENNAN
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
N.S. UNI-GLOVES SDN. BHD.
UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125
TORRANCE CA 90501 
510(k) No: K000688
510(k) Summary
SE Decision Made: 04/12/2000
Attn: ROBERT D VANDER LEEK
UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
N.S. UNI-GLOVES SDN. BHD.
UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125
TORRANCE CA 90501 
510(k) No: K000689
510(k) Summary
SE Decision Made: 04/28/2000
Attn: ROBERT D VANDER LEEK
3D MANUAL COARSE MANIPULATOR MN-188NE
NARISHIGE CO., LTD.
27-9 MINAMIKARASUYAMA 4-CHOME
SETAGAY-KU, TOKYO  157-0 062
510(k) No: K001130
510(k) Summary
SE Decision Made: 04/21/2000
Attn: MITSUKO YONEYAMA
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
NARISHIGE CO., LTD.
27-9 MINAMIKARASUYAMA 4-CHOME
SETAGAY-KU, TOKYO  157-0 062
510(k) No: K001131
510(k) Summary
SE Decision Made: 04/21/2000
Attn: MITSUKO YONEYAMA
CARDIO-CARD INTERPRETATION SYSTEM I
NASIFF ASSOC., INC.
9422 LEBEAU LN.
BREWERTON NY 13029 
510(k) No: K993616
510(k) Statement
SE Decision Made: 04/10/2000
Attn: ROGER E NASIFF
QUIK-CAP
NEUROSCAN
45150 BUSINESS CT., SUITE 100
STERLING VA 20166 
510(k) No: K000865
510(k) Summary
SE Decision Made: 04/18/2000
Attn: DAVID B JONES
VITAPORT 3
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE CA 92612 -160
510(k) No: K000338
510(k) Summary
SE Decision Made: 04/26/2000
Attn: BONNIE BISHOP
STAT PROFILE PHOX PLUS ANALYZER
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM MA 02454 -914
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 
510(k) No: K000794
510(k) Summary
SE Decision Made: 04/10/2000
Attn: ROBERT H SCHIFFMAN
SOFTLINE SPRING CLIP
NOVARE SURGICAL SYSTEMS, INC.
10231 BUBB RD.
CUPERTINO CA 95014 
510(k) No: K000098
510(k) Summary
SE Decision Made: 04/12/2000
Attn: TERRY BUELNA
NUVASIVE TOWNLEY FACET SCREW
NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO CA 92131 
510(k) No: K994308
510(k) Summary
SE Decision Made: 04/18/2000
Attn: STEVE REITZLER
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
OPTIMAL IMAGING SYSTEMS, INC.
9344 NW 13TH ST. SUITE 200
MIAMI FL 33172 
510(k) No: K000415
510(k) Summary
SE Decision Made: 04/11/2000
Attn: JORGE MILLAN
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
ORASURE TECHNOLOGIES, INC.
1745 EATON AVE.
BETHLEHEM PA 18018 -179
510(k) No: K992918
510(k) Summary
SE Decision Made: 04/03/2000
Attn: R. SAM NIEDBALA
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
ORASURE TECHNOLOGIES, INC.
1745 EATON AVE.
BETHLEHEM PA 18018 -179
510(k) No: K993208
510(k) Summary
SE Decision Made: 04/03/2000
Attn: R. SAM NIEDBALA
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 
510(k) No: K001008
510(k) Summary
SE Decision Made: 04/12/2000
Attn: SUSAN D GOLDSTEIN-FALK
HEMISPHERE MODULAR CUP SYSTEM
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER UT 84020 
510(k) No: K000321
510(k) Statement
SE Decision Made: 04/10/2000
Attn: CAROL FREASIER
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER NY 14626 -510
510(k) No: K001133
510(k) Summary
SE Decision Made: 04/24/2000
Attn: MARLENE SHULMAN
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
ORTHOPAEDIC BIOSYSTEMS, LTD.
15990 N GREENWAY-HAYDEN LOOP SUITE 100
SCOTTSDALE AZ 85260 
510(k) No: K000797
510(k) Summary
SE Decision Made: 04/03/2000
Attn: MELODY F MARTIN
5.0MM SPINAL SCREWS
ORTHOTEC, L.L.C.
200 GREGORY LN. SUITE C-100
PLEASANT HILL CA 94523 -338
510(k) No: K994288
510(k) Summary
SE Decision Made: 04/10/2000
Attn: DAVID W SCHLERF
APPRAISE-CARDIO SAMPLE COLLECTION KIT
OSBORN GROUP, INC.
14901 WEST 117TH ST.
OLATHE KS 66062 
510(k) No: K993787
510(k) Summary
SE Decision Made: 04/14/2000
Attn: GILBERT P BOURK III
OSTEONICS SERIES 7000 AD TIBIAL TRAY
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE NJ 07401 -167
510(k) No: K983657
510(k) Summary
SE Decision Made: 04/06/2000
Attn: ELIZABETH A STAUB
MODEL 120
PALCO LABS, INC.
8030 SOQUEL AVE.
SANTA CRUZ CA 95062 
510(k) No: K994372
510(k) Statement
SE Decision Made: 04/28/2000
Attn: RICHELLA GOO
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 
510(k) No: K993756
510(k) Statement
SE Decision Made: 04/28/2000
Attn: SAID AWANG
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 
510(k) No: K000828
510(k) Statement
SE Decision Made: 04/07/2000
Attn: SAID AWANG
FLUROPERM 60-OK, PARAGON HDS-OK
PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA AZ 85204 
510(k) No: K000224
510(k) Summary
SE Decision Made: 04/17/2000
Attn: WILLIAM E MEYERS
STEROTACTIC LOCALIZATION DEVICE (SLD)
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON CT 06484 
510(k) No: K000832
510(k) Summary
SE Decision Made: 04/27/2000
Attn: PETER A LTMAN
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
PHOENIX MEDICAL TECHNOLOGY, INC.
HWY. 521 WEST, P.O. BOX 346
ANDREWS SC 29510 
510(k) No: K000223
510(k) Statement
SE Decision Made: 04/14/2000
Attn: GROVER C MIXON
DIXI 2
PLANMECA OY
ASENTAJANKATU 6
HELSINKI  00880 
510(k) No: K000428
510(k) Statement
SE Decision Made: 04/28/2000
Attn: LARS MORING
PM 2002 PROLINE/AEC
PLANMECA OY
ASENTAJANKATU 6
HELSINKI  00880 
510(k) No: K000163
510(k) Statement
SE Decision Made: 04/18/2000
Attn: LARS MORING
BICON-PLUS ACETABULAR COMPONENTS
PLUS ORTHOPEDICS
3550 GENERAL ATOMICS CT. BLDG. 15-100
SAN DIEGO CA 92121 -112
510(k) No: K992154
510(k) Summary
SE Decision Made: 04/06/2000
Attn: HARTMUT LOCH
UMBICUT
POLLAK (INTL.), LTD.
HAMLACHA 20, INDUSTRIAL ZONE
ROSH HA'AYIN  48091 
510(k) No: K000227
510(k) Statement
SE Decision Made: 04/27/2000
Attn: MICHAEL PORAT
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
510(k) No: K972610
510(k) Summary
SE Decision Made: 04/11/2000
Attn: JAMES D GUSTAFSON
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS MN 55433 -800
510(k) No: K993564
510(k) Summary
SE Decision Made: 04/28/2000
Attn: TIMOTHY J KAPPERS
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
PRISM ENTERPRISES, INC.
10 AUBREY COURT
SAN ANTONIO TX 78216 
510(k) No: K000444
510(k) Summary
SE Decision Made: 04/21/2000
Attn: JUDITH A HARBOUR
PRO.DUCT CATHETER, MODEL CTH03
PRO.DUCT HEALTH, INC.
1010 HAMILTON CT.
MENLO PARK CA 94025 
510(k) No: K000135
510(k) Summary
SE Decision Made: 04/10/2000
Attn: ANGELA B SOITO
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 
510(k) No: K000667
510(k) Summary
SE Decision Made: 04/28/2000
Attn: THIRUNAVUKARASU PEARIASAMY
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 
510(k) No: K000668
510(k) Summary
SE Decision Made: 04/28/2000
Attn: THIRUNAVUKARASU PEARIASAMY
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
PRUCKA ENGINEERING, INC.
13000 EXECUTIVE DR.
SUGAR LAND TX 77478 
510(k) No: K993414
510(k) Summary
SE Decision Made: 04/07/2000
Attn: MATTHEW W PRUCKA
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
PURE WATER, INC.
305 WEST MARKET ST.
ANDERSON SC 29624 
510(k) No: K993272
510(k) Summary
SE Decision Made: 04/10/2000
Attn: CYNTHIA P WALTERS
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
R4 TELEMEDICINE, INC.
1301 K ST. N.W. SUITE 800 EAST
WASHINGTON DC 20005 -333
510(k) No: K000443
510(k) Summary
SE Decision Made: 04/24/2000
Attn: THOMAS B SMITH
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
RADIOTHERAPEUTICS CORP.
1308 BORREGAS AVE.SUITE 200
SUNNYVALE CA 94089 
510(k) No: K000241
510(k) Statement
SE Decision Made: 04/14/2000
Attn: GARY CURTIS
LEVEEN NEEDLE ELECTRODE
RADIOTHERAPEUTICS CORP.
2685 MARINE WAY, SUITE 1408
MOUNTAIN VIEW CA 94043 
510(k) No: K982556
510(k) Statement
SE Decision Made: 04/06/2000
Attn: COLIN J NICHOLS
RANDOX CALCIUM
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, CO. ANTRIM  BT29  4QY
510(k) No: K000375
510(k) Statement
SE Decision Made: 04/05/2000
Attn: P. ARMSTRONG
RANDOX PREALBUMIN
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM  BT29  4QY
510(k) No: K000661
510(k) Statement
SE Decision Made: 04/13/2000
Attn: P ARMSTRONG
RANDOX FERRITIN
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM  BT29  4QY
510(k) No: K000662
510(k) Statement
SE Decision Made: 04/03/2000
Attn: P. ARMSTRONG
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
RD MEDICAL MFG., INC.
BO. FULLADOSA
CULEBRA PR 00775 
510(k) No: K001102
510(k) Summary
SE Decision Made: 04/20/2000
Attn: CARLOS A RODRIGUEZ-GARCIA
REDI-SCREEN
REDWOOD BIOTECH, INC.
1206 SESAME DR.
SUNNYVALE CA 94087 
510(k) No: K000979
510(k) Summary
SE Decision Made: 04/10/2000
Attn: JANIS FREESTONE
LIGHT BOND (QUICK CURE)
RELIANCE ORTHODONTIC PRODUCTS, INC.
1100 W. IRVING PARK RD.
SCHAUMBURG IL 60193 
510(k) No: K001048
510(k) Summary
SE Decision Made: 04/27/2000
Attn: KATHRYN B PATTERSON
LIFECARD CF COMPACT RECORDER
REYNOLDS MEDICAL LTD.
377 RT. 17 S.
HASBROUCK HEIGHTS NJ 07604 
510(k) No: K001025
510(k) Summary
SE Decision Made: 04/19/2000
Attn: GEORGE MYERS
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
RHINOMETRICS A/S
555 13TH ST. N.W.
WASHINGTON DC 20004 -110
510(k) No: K000406
510(k) Summary
SE Decision Made: 04/17/2000
Attn: HOWARD M HOLSTEIN
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD. P.O. BOX 50457
INDIANAPOLIS IN 46250 -045
510(k) No: K000096
510(k) Summary
SE Decision Made: 04/26/2000
Attn: JENNIFER TRIBBETT
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD. P.O. BOX 50457
INDIANAPOLIS IN 46250 -045
510(k) No: K000534
510(k) Summary
SE Decision Made: 04/05/2000
Attn: KAY A TAYLOR
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD. P.O. BOX 50457
INDIANAPOLIS IN 46250 -045
510(k) No: K994164
510(k) Summary
SE Decision Made: 04/13/2000
Attn: JENNIFER TRIBBETT
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD. P.O. BOX 50457
INDIANAPOLIS IN 46250 -045
510(k) No: K994165
510(k) Summary
SE Decision Made: 04/07/2000
Attn: JENNIFER TRIBBETT
ELECSYS THYROGLOBULIN CALCHECK
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD. P.O. BOX 50457
INDIANAPOLIS IN 46250 -045
510(k) No: K001015
510(k) Summary
SE Decision Made: 04/27/2000
Attn: KAY A TAYLOR
HYSTALOG HSG CATHETER
ROCKET MEDICAL PLC
WEAR IND. ESTATE DISTRICT 6
WASHINGTON, TYNE & WEAR  NE37  1NE
510(k) No: K000340
510(k) Summary
SE Decision Made: 04/19/2000
Attn: L. TODD
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
ROCKET MEDICAL PLC
WARE INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR  NE37  1NE
510(k) No: K000205
510(k) Summary
SE Decision Made: 04/19/2000
Attn: LES TODD
SUNI MAX
SATELEC
70 WALNUT ST.
WELLESLEY MA 02481 
510(k) No: K000049
510(k) Summary
SE Decision Made: 04/04/2000
Attn: JACQUELINE E MASSE
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 
510(k) No: K000390
510(k) Summary
SE Decision Made: 04/12/2000
Attn: JANNA P TUCKER
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 
510(k) No: K000391
510(k) Summary
SE Decision Made: 04/12/2000
Attn: JANNA P TUCKER
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 
510(k) No: K000867
510(k) Summary
SE Decision Made: 04/21/2000
Attn: CHEAH CHOR HEE
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
SGMP CO., LTD.
181 MOO 6, TAMBOL KAMPAENGPETCH, RATTAPHUM
SONGKHLA  90180 
510(k) No: K000868
510(k) Summary
SE Decision Made: 04/20/2000
Attn: CHEAH CHOR HEE
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD., CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI   
510(k) No: K000872
510(k) Statement
SE Decision Made: 04/05/2000
Attn: JOHN LAI
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD., CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI   
510(k) No: K000953
510(k) Statement
SE Decision Made: 04/20/2000
Attn: JOHN LAI
NITRILE EXAM GLOVE, POWDER FREE, BLUE
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD.
198 AVENUE DE D'EMERALD
SPARKS NV 89434 
510(k) No: K000670
510(k) Summary
SE Decision Made: 04/12/2000
Attn: JANNA P TUCKER
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 
510(k) No: K000584
510(k) Summary
SE Decision Made: 04/12/2000
Attn: JANNA P TUCKER
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE  DD2 1 SW
510(k) No: K000398
510(k) Statement
SE Decision Made: 04/17/2000
Attn: EILEEN MCCAFFERTY
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
SIAM SEMPERMED CORP. LTD.
30798 US HWY 19 NORTH
PALM HARBOR FL 34684 
510(k) No: K000323
510(k) Summary
SE Decision Made: 04/05/2000
Attn: JOY LANCASTER
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
SIAM SEMPERMED CORP. LTD.
30798 US HWY 19 NORTH
PALM HARBOR FL 34684 
510(k) No: K000329
510(k) Summary
SE Decision Made: 04/05/2000
Attn: JOY LANCASTER
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
SIAM SEMPERMED CORP. LTD.
30798 US HWY 19 NORTH
PALM HARBOR FL 34684 
510(k) No: K000330
510(k) Summary
SE Decision Made: 04/05/2000
Attn: JOY LANCASTER
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS MO 63103 
510(k) No: K000527
510(k) Summary
SE Decision Made: 04/07/2000
Attn: WILLIAM R GILBERT
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS MO 63103 
510(k) No: K000528
510(k) Summary
SE Decision Made: 04/07/2000
Attn: WILLIAM R GILBERT
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL MN 55112 
510(k) No: K000942
510(k) Summary
SE Decision Made: 04/27/2000
Attn: LISA STONE
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE NH 03431 
510(k) No: K993619
510(k) Summary
SE Decision Made: 04/28/2000
Attn: TIMOTHY J TALCOTT
SONADA ULTRASOUND SYSTEM
SONOVISION CORP.
377 ROUTE 17 SOUTH SUITE 204
HASBROUCK HEIGHTS NJ 07604 
510(k) No: K993092
510(k) Statement
SE Decision Made: 04/14/2000
Attn: PAUL SCHNEIDER
ESKA MODULAR HIP SYSTEM
SPECS USA, INC.
635 SOUTH ORANGE AVE.
SARASOTA FL 34236 
510(k) No: K993027
510(k) Summary
SE Decision Made: 04/06/2000
Attn: THOMAS P MONKUS
CHILI VIDEO, CHILI VIDEOPRO
STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK
24 EASTMAN AVE. C5
BEDFORD NH 03110 
510(k) No: K000411
510(k) Summary
SE Decision Made: 04/14/2000
Attn: JIM DOYLE
PROVEN KNEE SYSTEM
STELKAST COMPANY
800 VINIAL STREET, SUITE B-210
PITTSBURGH PA 15212 
510(k) No: K000113
510(k) Statement
SE Decision Made: 04/04/2000
Attn: DONALD A STEVENS
STERLTECH WATER PURIFIER
STERLTECH, INC.
60 LAKESIDE BLVD. WEST
WATERBURY CT 06708 
510(k) No: K000941
510(k) Statement
SE Decision Made: 04/06/2000
Attn: JOHN R NOLL
PARA 12 PLUS RETICS
STRECK LABORATORIES, INC.
14124 INDUSTRIAL RD.
OMAHA NE 68145 -062
510(k) No: K000945
510(k) Summary
SE Decision Made: 04/18/2000
Attn: PAUL KITTELSON
DEVILBISS NEBULIZER MODEL 800
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET PA 15501 
510(k) No: K993492
510(k) Summary
SE Decision Made: 04/21/2000
Attn: FRANK CLEMENTI
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
SURETEX PROPHYLACTICS LTD.
1500 INDUSTRIAL RD. P.O. 1252
DOTHAN AL 36302 
510(k) No: K000408
510(k) Summary
SE Decision Made: 04/19/2000
Attn: LON D MCINVAIN
KERR GEL ETCHANT
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE CA 92867 
510(k) No: K000954
510(k) Summary
SE Decision Made: 04/28/2000
Attn: ORLANDO TADEO, JR.
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
SYNTHES (USA)
P.O. BOX 1766 1690 RUSSELL ROAD
PAOLI PA 19301 -122
510(k) No: K000684
510(k) Summary
SE Decision Made: 04/28/2000
Attn: ANGELA J SILVESTRI
SYNTHES (USA) WRIST FUSION PLATES (WFP)
SYNTHES (USA)
1690 RUSSELL RD. POST OFFICE BOX 1766
PAOLI PA 19301 
510(k) No: K000558
510(k) Summary
SE Decision Made: 04/14/2000
Attn: SHERI L MUSGNUNG
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
510(k) No: K000555
510(k) Statement
SE Decision Made: 04/12/2000
Attn: KOK-KEE HON
TFX MEDICAL STYLET CATHETER
TFX MEDICAL GROUP
TALL PINES PARK
JAFFREY NH 03452 
510(k) No: K992664
510(k) Summary
SE Decision Made: 04/13/2000
Attn: JULIE A BEAUMONT
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 
510(k) No: K000701
510(k) Statement
SE Decision Made: 04/27/2000
Attn: JAY H GELLER
OPART, MODEL MRT-600
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO CA 94080 -688
510(k) No: K000549
510(k) Summary
SE Decision Made: 04/20/2000
Attn: KEN NEHMER
UM-L25
UNION MEDICAL ENGENEERING CO., LTD.
1200 N.W. 78TH ST. SUITE 110
MIAMI FL 33126 
510(k) No: K000222
510(k) Statement
SE Decision Made: 04/19/2000
Attn: ANNIE VELEZ
DIGITAL INFLECTION RIGIDOMETER (DIR)
UROAN XXI ELECTROMEDICINA
C/ ANSELM TURMEDA, 12 PALMA DE MALLORCA
BALEARES  07003 
510(k) No: K000194
510(k) Summary
SE Decision Made: 04/10/2000
Attn: VICTORIA GAYA
CAVERMAP SURGICAL AID
UROMED CORP.
1400 PROVIDENCE HWY.
NORWOOD MA 02062 
510(k) No: K000507
510(k) Summary
SE Decision Made: 04/21/2000
Attn: FREDERICK TOBIA
EROS-CLITORAL THERAPY DEVICE (CTD)
UROMETRICS, INC.
445 ETNA ST., SUITE 56
ST. PAUL MN 55106 
510(k) No: DEN000006
 
SE Decision Made: 04/28/2000
Attn: PHILIP A MESSINA
INTERVENTIONAL BODY COIL
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA OH 44202 
510(k) No: K000437
510(k) Summary
SE Decision Made: 04/14/2000
Attn: RONY THOMAS
LEMAITRE OCCLUSION CATHETER
VASCUTECH, INC.
164 MIDDLESEX TURNPIKE
BURLINGTON MA 01803 
510(k) No: K992942
510(k) Statement
SE Decision Made: 04/13/2000
Attn: TRENT G KAMKE
VISION R/F TILTING TABLE
VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK IL 60131 
510(k) No: K000412
510(k) Statement
SE Decision Made: 04/24/2000
Attn: JEFFERY N MOELLER
BODYGUARD
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA NJ 07512 
510(k) No: K000441
510(k) Summary
SE Decision Made: 04/11/2000
Attn: ANTHONY MARTINO
MEDVIZER PACS, MODEL RELEASE 2000
VITEL NET
8201 GREENSBORO DR. SUITE 820
MCLEAN VA 22102 
510(k) No: K000557
510(k) Summary
SE Decision Made: 04/24/2000
Attn: ALLEN IZADPANAH
WAKO L-TYPE UN TEST
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND VA 23237 
510(k) No: K993925
510(k) Summary
SE Decision Made: 04/03/2000
Attn: TONYA MALLORY
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE CT 06477 
510(k) No: K000768
510(k) Statement
SE Decision Made: 04/11/2000
Attn: MICHAEL MALIS
ACTICOAT FOAM DRESSING
WESTAIM BIOMEDICAL, INC.
ONE HAMPTON RD. SUITE 302
EXETER NH 03833 
510(k) No: K000051
510(k) Summary
SE Decision Made: 04/05/2000
Attn: Steve Chartier
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 
510(k) No: K000971
510(k) Summary
SE Decision Made: 04/14/2000
Attn: YUE WAH CHOW
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
ZCV ,INC.
298 FERNWOOD AVE.
EDISON NJ 08837 
510(k) No: K991060
510(k) Summary
SE Decision Made: 04/06/2000
Attn: PRISCILLA WHITEHEAD COX

Information on Releasable 510(k)s

Database Updated 12/15/2014

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