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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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powder-free nitrile patient examination glove, white (non-colored), blue and green colored PERUSAHAAN GETAH ASAS SDN BHD k031591 06/26/2003
calcium hydroxylapatite implant, icc and 0.5cc, models 8038-3, 8037-3 BIOFORM, INC. k030682 06/27/2003
modification to hermes o.r. control center COMPUTER MOTION, INC. k031382 06/30/2003
hl888ra HEALTH & LIFE CO., LTD. k031835 07/01/2003
personal digital workstation (pdw); film digitizing camera and digital workstation MAXXVISION, LLC k031372 07/02/2003
ultraflex venous cannula, model 970xx and cb970xx MEDTRONIC PERFUSION SYSTEMS k031827 07/02/2003
model 780 HUDSON RESPIRATORY CARE, INC. k031383 07/07/2003
cobas integra cholesterol gen. 2 ROCHE DIAGNOSTICS CORP. k031824 07/09/2003
premier 9000 8 channel phased array ctl spine coil USA INSTRUMENTS, INC. k031366 07/11/2003
hedrocel vertebral body replacement, model 06-172-00xx1 IMPLEX CORP. k031823 07/11/2003

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