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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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world knee total knee systems Signature Orthopaedics Pty, Ltd. k190577 11/27/2019
digital intraoral imaging plate system Fsusen Technology Co., Ltd. k192766 12/05/2019
rxsight insertion device Rxsight, Inc. k192926 01/17/2020
mts omadacycline 0.002 - 32 ug/ml Liofilchem S. R. L. k200180 03/20/2020
cangaroo envelope (small), cangaroo envelope (medium), cangaroo envelope (large), cangaroo envelope (extra large), cangaroo enevlope (extra extra large) (subq) Aziyo Biologics, Inc. k201313 06/15/2020
bd phaseal optima closed system drug transfer device Becton, Dickinson and Company k201099 08/12/2020
irrisept wound debridement and cleansing system Irrimax Corporation k202222 12/14/2020
everyway analog otc tens, model n103a/n302 Everyway Medical Instruments Co.,Ltd k202849 12/22/2020
surgical face mask Hunan Eexi Technology & Service Co., Ltd. k202161 03/10/2021
system 1e liquid chemical sterilant processing system, system 1 endo liquid chemical sterilant processing system, model p6800, system 1 endo liquid chemical sterilant processing system, model p6900, s40 sterilant concentrate STERIS Corporation k210737 05/12/2021

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