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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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electrode for urinary incontinence GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD k140265 01/23/2015
integra external fixation system ASCENSION ORTHOPEDIC k140463 10/10/2014
starceram H.C. STARCK CERAMICS GMBH k140924 06/05/2014
powder-free nitrile examination gloves, orange, color HL RUBBER INDUSTRIES SDN BHD k141021 08/26/2014
truwave disposable pressure transducer EDWARDS LIFESCIENCES, LLC. k141495 09/03/2014
rapidfret oral fluid assay for amphetamine, rapidfret oral fluid amphetamine calibrator set, rapidfret oral fluid amphetamine control set BIOPHOR DIAGNOSTICS, INC. k141748 05/20/2015
stgc-lordotic CARDINAL SPINE, LLC k142030 01/23/2015
benchmark intracranial access system PENUMBRA, INC. k142321 01/26/2015
zimmer periarticular plating system ZIMMER, INC. k142579 10/22/2014
traumacad mobile release 1.0 Voyant Health Ltd k142923 03/05/2015

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