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U.S. Department of Health and Human Services

510(K) Premarket Notification
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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
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
cgba-032a, aquilion prime self-propelled scan base kit for ivr-ct TOSHIBA MEDICAL SYSTEMS CORPORATION k143223 01/12/2015
inclusive® zirconia abutments compatible with: zimmer screw-vent, biomet 3i certain and nobel biocare nobelreplace implants PRISMATIK DENTALCRAFT, INC. k143515 10/01/2015

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