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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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pbs model 701a compression therapy device MEGO AFEK k060220 02/09/2006
medtox oxycodone MEDTOX DIAGNOSTICS, INC. k060351 05/12/2006
lifestent flexstar xl biliary stent system EDWARDS LIFESCIENCES, LLC. k060487 03/23/2006
comprehensive primary shoulder stems BIOMET MANUFACTURING CORP. k060692 05/30/2006
modification to: hi-art system TOMOTHERAPY INCORPORATED k060912 04/19/2006
stasis - i, ii and iii; serathan - a, b; intrin - ea, si calcium chloride 0.02m; fibrinogen control-normal, low WORTHAM LABORATORIES INC k060968 05/15/2007
g-prox endoscopic grasper USGI MEDICAL k061276 12/06/2006
powder free latex examination gloves, natural or blue colour and with protein content labeling claim (50 ug or less) MEDIPURE CORPORATION (M) SDN. BHD. k061551 08/24/2006
defibrillator cable tester, model dt2200 MEDICAL DEVICES/PADPRO, INC. k061606 06/21/2006
acuson x300 diagnostic ultrasound system SIEMENS MEDICAL SOLUTIONS USA, INC. k061946 07/21/2006

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