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U.S. Department of Health and Human Services

510(K) Premarket Notification
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disposable hemoclip Beijing ZKSK Technology Co.,Ltd k213217 11/14/2022
sol-guard safety pull button collection set Sol-Millennium Medical, Inc. k213718 08/30/2022
bd univia rightfit enteral extension sets and transitional adapters MPS Medical, Inc. k200082 07/30/2020
powder free nitrile examination glove (aqua green) Riverstone Resources SDN BHD k200326 04/09/2020
sientra opus silicone gel breast implant sizer Sientra, Inc k200706 11/16/2020
infrared light therapy led facial light therapy mask-derma plus, photons facial skin care machine led beauty mask therapy beauty machine Ningbo Hesi Electric Co., Ltd k200983 07/14/2021
ethicon circular stapler, ethicon circular stapler -xl sealed Ethicon Endo-Surgery LLC k201280 07/27/2020
surgical face mask Amphastar Nanjing Pharmaceuticals, Inc. k201545 02/12/2021
light cure dental adhesive Rizhao HuGe Biomaterials Company, Ltd. k201787 09/25/2020
air pressure therapy system Xiamen Weiyou Intelligent Technology Co.,Ltd k201935 06/22/2021

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