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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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serranator pta serration balloon catheter Cagent Vascular, LLC k213728 12/15/2021
axtiha stand-alone alif system Innovasis, Inc. k212967 10/15/2021
smartband emr kit (sb-emr-k, sb-emr-k-12, sb-emr-k-9.4), smartband emr pack (sb-emr-p, sb-emr-p-12, sb-emr-p-9.4), smartsnare emr hexagonal snare (ss-230-1 or packaged with kit) Steris Corporation k212860 10/07/2021
disposable medical mask Fujian Kang Chen Daily Necessities CO., LTD k203455 09/13/2021
vitek 2 ast-gram negative piperacillin / tazobactam (<=4 - =>128 µg/ml) bioMerieux, Inc k211630 08/30/2021
clearblue® early digital pregnancy test SPD Swiss Precision Diagnostics GmbH k200913 08/13/2021
surgical gowns Jiangsu Province Jianerkang Medical Dressing Co., Ltd k210215 07/07/2021
estar-z Osstem Implant Co., Ltd. k210097 07/02/2021
powder free nitrile surgical glove, sterile, tested for use with chemotherapy drugs WRP ASIA PACIFIC SDN BHD k203030 06/11/2021
6ms invisible aligner SMS OPCO, LLC k210652 06/02/2021

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