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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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emit ii plus buprenorphine assay, emit ii plus specialty drug calibrator/control level 1, level 2 level 3, level 4, emit ii plus specialty drug control negative, emit ii plus specialty drug control positive SIEMENS HEALTHCARE DIAGNOSTICS, INC. k150606 10/23/2015
inclusive® zirconia abutments compatible with: zimmer screw-vent, biomet 3i certain and nobel biocare nobelreplace implants PRISMATIK DENTALCRAFT, INC. k143515 10/01/2015
azur cx detachable 35 coils Micro Vention, Inc. k151358 09/25/2015
gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. k151592 09/24/2015
leforte system ii Jeil Medical Corporation k150965 09/17/2015
locator rtx ZEST ANCHORS, INC. k150295 07/24/2015
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
gc kommonbase GC Orthodontics America Inc. k143667 05/07/2015
cardinal health external fixation system CARDINAL HEALTH k150579 04/29/2015
traumacad mobile release 1.0 Voyant Health Ltd k142923 03/05/2015

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