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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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vitros immunodiagnostic products 25-oh vitamin d total reagent pack, vitamin d total calibrators Ortho-Clinical Diagnostics, Inc. k121608 02/15/2013
viscostat clear ULTRADENT PRODUCTS, INC. k123215 02/05/2013
powder free latex patient examination gloves, with protein content labeling claim, natural color ASSURGUARD SDN. BHD. k123757 02/01/2013
evis exera iii gastrointestinal videoscope olympus gixp190n OLYMPUS MEDICAL SYSTEMS CORPORATION k123317 12/11/2012
powder-free vinyl patient examination gloves, clear(non-colored) SHANDONG HONGXIN CHEMICALS CO., LTD k122828 12/10/2012
loqteq proximal humerus plate 3.5, short loqteq proximal humerus plate 3.5, long AAP IMPLANTATE AG k121495 12/07/2012
zimmer trabecular metal reverse shoulder system, non-porous humeral stems ZIMMER, INC. k122692 12/03/2012
speedlock hip knotless fixation implant speedlock hip drill speedlock hip guide crown tip speedlock hip pathfinder ARTHROCARE CORPORATION k120943 09/21/2012
quanta flash dgp iga, quanta flash dgp igg, quanta flash dgp iga calibrators, quanta flash dgp igg calibrators INOVA DIAGNOSTICS, INC. k113863 09/20/2012
arm-type fully automatic digital blood pressure monitor, wrist-type fully automatic digital blood pressure monitor SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. k120554 08/10/2012

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