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U.S. Department of Health and Human Services

510(K) Premarket Notification

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benchmark intracranial access system PENUMBRA, INC. k142321 01/26/2015
avs® al and align peek spacers, avs® pl and unilif peek spacers, avs® tl peek spacer, avs® navigator peek spacer, avs® aria peek spacer, acculif tl and pl cage, avs® anchor-l spacer, aero-al lumbar cage system STRYKER CORPORATION k143163 01/26/2015
electrode for urinary incontinence GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD k140265 01/23/2015
stgc-lordotic CARDINAL SPINE, LLC k142030 01/23/2015
cgba-032a, aquilion prime self-propelled scan base kit for ivr-ct TOSHIBA MEDICAL SYSTEMS CORPORATION k143223 01/12/2015
health expert elctronic stimulator SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED k133929 11/12/2014
e-fit ef-1280 ems machine FIT-PRO KFT LTD. k133225 10/24/2014
zimmer periarticular plating system ZIMMER, INC. k142579 10/22/2014
integra external fixation system ASCENSION ORTHOPEDIC k140463 10/10/2014
truwave disposable pressure transducer EDWARDS LIFESCIENCES, LLC. k141495 09/03/2014

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