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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
Date
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starlight, model pd9012 F.P. RUBINSTEIN Y CIA S.R.L. k073317 09/03/2008
re-zorb plating system ACUTE INNOVATIONS LLC k081588 09/03/2008
emp-2100 full digital ultrasound diagnostic device SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD. k081873 07/16/2008
accuflow and accuflux elastomeric infusion pump Westmed, Inc. k081905 07/15/2008
s40 clinical analyzer, s test ip, s test ua ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. k072141 06/24/2008
onetouch zoom diabetes management program LIFESCAN, INC. k081318 06/09/2008
normoflo irrigation fluid warmer, models h-1100, h-1129, normoflo irrigation warming set, models, ir-40, ir-500, ir-600, SMITHS MEDICAL ASD, INC. k072080 06/02/2008
pajunk's kit for balloon aided laparoscopy PAJUNK GMBH MEDIZINTECHNOLOGIE k080654 05/08/2008
stryker antimic catheter STRYKER INSTRUMENTS, INSTRUMENTS DIV. k072702 03/19/2008
vitek 2 gram negative piperacillin/tazobactam BIOMERIEUX, INC. k080107 02/28/2008

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