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U.S. Department of Health and Human Services

510(K) Premarket Notification
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disposable medical mask Fujian Kang Chen Daily Necessities CO., LTD k203455 09/13/2021
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
gsp neonatal total galactose kit PerkinElmer Inc. k190335 11/06/2019
ureteral stent open tip/closed tip/intraoperative tip, ureteral stent via ureterorenoscope open tip/closed tip, pediatric ureteral stent open tip/closed tip, mono j urinary diversion ureteral stent open tip/closed tip, multiloop ureteral stent open tip/closed tip Allwin Medical Devices, Inc. k190659 12/02/2019
vial adapter ø20 mm , vial adapter ø13 mm Avenir Performance Europeenne Medical (APEM) k190816 11/19/2019
980nm diode laser therapy device Shanghai Apolo Medical Technology Co., Ltd. k191349 08/16/2019
modular power standing system Motion Concepts k191376 08/13/2019
pulse oximeter Shenzhen Yimi Life-Technology Co.,Ltd. k191430 10/18/2019
aocup lens case with aodisc Alcon Laboratories, Inc. k191795 07/31/2019
ag foam dressing non-adhesive, ag foam dressing adhesive, silicone ag foam dressing, silicone ag foam dressing with border Winner Medical Co., Ltd. k191819 05/14/2020

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