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U.S. Department of Health and Human Services

510(K) Premarket Notification

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41 to 50 of 500 Results *
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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ultra v therapeutic ultrasound EXCEL TECH. LTD. k001166 07/07/2000
ultima metal-on-metal acetabular cup DEPUY ORTHOPAEDICS, INC. k001523 08/10/2000
ultegra system rapid platelet function assay (rpfa) ACCUMETRICS, INC. k011337 10/16/2001
trojan extra large latex condom ARMKEL, LLC. k001212 05/09/2000
triage bnp calibration verification controls BIOSITE INCORPORATED k000231 03/02/2000
triage b-type natriuretic peptide (bnp) controls BIOSITE INCORPORATED k000230 02/29/2000
trepchek treponemal antibody eia PHOENIX BIOTECH CORP. k001552 10/19/2000
transq3 IOMED, INC. k001522 10/18/2000
transpak (vitreoretinal infusion pak), models 90000, 90001 RETINALABS.COM k000416 05/08/2000
transanal endoscopic microsurgery (tem) combination system and instrument set, instrument set for the transanal endoscop RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000180 03/02/2001

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