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U.S. Department of Health and Human Services

510(K) Premarket Notification
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xingda nitrile powder free patient examination gloves, blue color XINGDA MEDICAL PRODUCTS CO., LTD. k152720 03/10/2016
leva spacer system SPINE WAVE, INC. k153222 04/15/2016
maxfit ii dental implant system Taiwan Implant Technology Company, Ltd. k151588 04/25/2016
guiding catheter Texas Medical Technologies, Inc. k153703 05/12/2016
masterloc stem MEDACTA INTERNATIONAL k160289 05/20/2016
multiscan g-arm system BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD k160984 07/20/2016
st internal fixture system T-PLUS IMPLANT TECH. CO., LTD. k152787 07/22/2016
sysmex automated blood coagulation analyzer cs-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH k161312 09/01/2016
s9 vpap adapt, vpap adapt, aircurve 10 asv RESMED LTD k160822 09/09/2016
distal radius plating system Miami Device Solutions, LLC k162635 10/21/2016

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