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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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sandshark injectable anchor (sia) system Stimwave Technologies Inc. k191466 11/07/2019
tk sterile piston syringe without needle Anhui Tiankang Medical Technology Co.,Ltd. k191642 01/06/2020
stryker cmf medpor priority customized implant kit Stryker Leibinger GmbH & Co. KG k191916 08/15/2019
yushan x-ray flat panel detector InnoCare Optoelectronics Corp. k191939 08/29/2019
cpr face shield Firstar Healthcare Company Limited (Guangzhou) k192285 11/25/2020
youjia unscented tampon with plastic applicators Qingdao Youjia Hygiene Technology Co., Ltd k192557 02/13/2020
liaison® folate Diasorin Inc. k192586 05/06/2020
nemocast Software Nemotec S.L. k193003 06/05/2020
esophageal stethoscope 9 french, esophageal stethoscope 12 french, esophageal stethoscope 18 french, esophageal stethoscope, 24 french DeRoyal Industries, Inc. k193027 04/02/2020
pre-milled blank Arum Dentistry Co. Ltd k193425 03/09/2020

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