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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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surgical gowns Jiangsu Province Jianerkang Medical Dressing Co., Ltd k210215 07/07/2021
intellifat disposable adipose tissue harvesting and transfer kit, intellifat body on demand (bod) kit Millennium Medical Technologies Inc (DBA Cellmyx) k210528 03/16/2022
6ms invisible aligner SMS OPCO, LLC k210652 06/02/2021
bd quincke spinal needle, bd whitacre spinal needle, bd spinal introducer needle Becton, Dickinson and Company k210978 12/22/2021
intrelief EasyMed Instruments Co., Ltd. k211263 12/30/2021
vitek 2 ast-gram negative piperacillin / tazobactam (<=4 - =>128 µg/ml) bioMerieux, Inc k211630 08/30/2021
or head holder lucy with headcoilset siemens 1.5t, or head holder lucy with headcoilset siemens 3t, or head holder lucy with headcoilset philips 1.5t, or head holder lucy with headcoilset philips 3t NORAS MRI products GmbH k211658 03/03/2022
immunocap allergen f433, allergen component rtri a 14 ltp, wheat, immunocap allergen f416, allergen component rtri a 19 omega-5 gliadin, wheat, immunocap allergen f449, allergen component rses i 1 sesame seed Phadia AB k212181 08/03/2022
hp458e electrically powered wheelchair Kunshan Hi-Fortune Health Products Co., Ltd. k212503 01/18/2022
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

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