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U.S. Department of Health and Human Services

510(K) Premarket Notification
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nitta m&t safety box Nitta M&T (Thailand) Co., Ltd. k211464 09/14/2021
ipl hair remover, model: g993, g996, g998 and g885 Shenzhen Mywin Technology Co., Ltd. k211368 10/04/2021
ortho mi system Osteonic Co., Ltd. k211992 10/15/2021
multi-unit abutment, multi-unit angled abutment MegaGen Implant Co. Ltd. k203808 10/20/2021
finebeam SNJ Co., Ltd. k202288 11/19/2021
unico high performance surgical mask, unico high performance surgical mask with face shield Unicoglobal, Inc. k210147 12/22/2021
eyebox (model ebx-4) Oculogica, Inc. k212310 12/22/2021
nuvasive thoracolumbar interbody systems: nuvasive coroent thoracolumbar system, nuvasive coroent xl interfixated system, brigade system, brigade lateral system, base interfixated titanium system, coalesce thoracolumbar interbody fusion system, nuvasive cohere thoracolumbar interbody system, nuvasi NuVasive, Incorporated k203714 12/23/2021
skypro, sp02 mask (3) Skypro Medical Supplies Company k202255 12/24/2021
powder free nitrile examination gloves, blue chemotest Careglove Global SDN. BHD. k211666 01/09/2022

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