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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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endoscopy video camera system Vision Systems Group, A Division of Viking Systems k081585 06/20/2008
dimension vista system igg flex reagent cartridge, dimension vista system protein 1 calibrator, and dimension vista syst Dade Behring, Inc. k081161 07/28/2008
haida model hd11 manual wheelchair Jiangyin East China Medical Technology Co., Ltd. k082274 08/19/2008
medrad stellant ct injector system with p3t cardiac Medrad, Inc. k082905 01/12/2009
spec model m-31 Source Production & Equipment Co., Inc. k090366 04/22/2009
baixin intravascular administration set Anhui Kangda Medical Products Co., Ltd. k083687 06/11/2009
gii spinal fixation system, gii-ti-poly axial screw Co-Ligne AG k083567 09/14/2009
azur peripheral hydrocoil endovascular embolization system-detachable 35, models 45-450405, 45-450410, 45-450610 MicroVention, Inc. k093002 10/28/2009
powder free latex examination gloves, blue, tested for use with chemotherapy drugs Gx Corporation Sdn Bhd k091643 11/02/2009
full automatic (nibp) blood pressure monitor, model hl168kb Health & Life Co., Ltd. k092163 11/16/2009

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