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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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Decision
Date
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surgical gown (sterile); surgical gown (non-sterile) Allmed Medical (Hubei) Protective Products Co., Ltd k221637 09/29/2022
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
ameditech immutest multi-drug screen panel ii AMEDITECH, INC. k042975 12/29/2004
iso-bac instrument wrap AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL k802919 02/02/1981
disk AMERICAN HEARTLINE, INC. k812695 10/13/1981
amp direct vascular monitoring system AMERICAN MEDICAL PRODUCTS, INC. k792646 02/11/1980
amp 80/2 outflow monitor modification AMERICAN MEDICAL PRODUCTS, INC. k823827 03/17/1983
inflatable penile prosth. - cylinder AMERICAN MEDICAL SYSTEMS, INC. k830048 04/12/1983
scs 17-01 Anika Therapeutics, Inc. k190956 01/30/2020
solace post-operative pain relief infusion system APEX MEDICAL TECHNOLOGIES, INC. k060933 05/09/2006

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