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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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Decision
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zimmer periarticular locking plate system: distal humeral and proximal ulna plates ZIMMER, INC. k082078 11/03/2008
powder-free vinyl patient examination gloves ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. k091663 07/27/2009
z-box/z-tilt breast and thoracic positioning device, z-square indexing system, z-foam, z-bar index bar, z-pulls patient hand grip overlay ZDi, Solutions, LLC k162002 11/01/2016
non-sterile, powder free nitrile examination gloves, low dermatitis potential, and tested for use with chemotherapy drugs blue-ac YTY Industry (Manjung) Sdn Bhd k200453 05/01/2020
tissure retractors XOMED, INC. k791122 07/10/1979
pressure therapy system pt1003 Xiamen Senyang Co., Ltd. k181409 02/19/2019
xenta drug screen cup, xenta drug screen dipcard Xenta Biomedical Science Co., Ltd. k222955 02/06/2023
xenta drug screen cup, xenta drug screen dipcard Xenta Biomedical Science Co., Ltd. k231137 05/19/2023
intice™-c porous ti cervical interbody system X-Spine Systems, Inc. k173832 05/17/2018
powder free blue latex patient examination gloves, tested for use with chemotherapy drugs with a protein content label WRP ASIA PACIFIC SDN. BHD. k083409 07/29/2009

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