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U.S. Department of Health and Human Services

510(K) Premarket Notification
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acculif tl and pl cage Stryker Corporation k160715 07/08/2016
gore tips set, gore tips sheath, gore tips needle Creganna Medical Aslo Business AS Cregganna Tactx Medical k152913 07/21/2016
source production & equipment co., inc. model m14 192iridium brachytherapy source Source Production and Equipment Co., Inc. k162573 11/04/2016
vanguard dental unit Ritter Concept GmbH k161734 12/09/2016
echelon flex 45mm powered plus articulating endoscopic linear cutters, echelon endopath endoscopic linear cutter reloads, 45mm Ethicon Endo-Surgery, LLC k163454 01/05/2017
verify sixcess steam indicators, verify sixcess flash indicators, verify bowie dick test pack, verify sixcess challenge pack, verify sixcess fp challenge pack Steris Corporation k162758 03/21/2017
sterile polyisoprene surgical powder free glove tested for use with chemotherapy drugs Tg Medical Sdn. Bhd. k171276 08/21/2017
phoenix clinical icon Phoenix Technology Group, Inc. Dba Phoenix Clinical k170527 09/15/2017
dash 3 enfit syringe, dash 3 eccentric enfit syringe, dash 3 plus enfit syringe, dash 3 plus eccentric enfit syringe, dash 3 enfit low dose tip syringe Intervene Group Limited k170371 10/20/2017
enflu 18 (enflufocon a) daily wear contact lens Contamac, Ltd. k171575 10/24/2017

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