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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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single use arthroscopic electrode (with pencil) Modern Medical Equipment Manufacturing Limited k170703 05/31/2018
variax 2 foot system Stryker GmbH k170771 05/08/2017
sterile nitrile surgical powder free gloves tested for use with chemotherapy drugs and sterile latex surgical powder free gloves Top Glove SDN BHD k171279 10/12/2017
boston xo (hexafocon a), boston xo2 (hexafocon b) BAUSCH + LOMB Incorporated k171404 07/17/2017
bladder scanner (model: padscan ds3, padscan z3, padscan z5) Avantsonic Technology Co., Ltd. k171528 01/24/2018
electrodes with snap / electrodes with pigtail Shenzhen Konmed Technology Co., Ltd k171722 01/10/2018
visionary optics scleral contact lens (roflufocon d, roflufocon e, hexafocon a, hexafocon b) Visionary Optics LLC k171950 08/16/2017
combo stimulator mt9000, combo stimulator lt7102, tens stimulator intensity 10 Shenzhen Dongdixin Technology Co., Ltd. k171978 10/02/2017
construx® mini ptc spacer system, forza® ptc spacer system, pillar® sa ptc spacer system Orthofix Inc. k172437 11/02/2017
hemodraw plus closed blood sampling system with logical transducer kit, hemodraw plus closed blood sampling system with transtar transducer kit Smiths Medical ASD, Inc. k172458 11/09/2017

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