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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
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urine monovette boric acid SARSTEDT, INC. k024237 04/14/2003
urine collection bag type 740ap BIO D CORP. k802735 12/18/1980
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
ultratens Shenzhen Dongdixin Technology Co., Ltd k142976 08/26/2015
ultrachem gluc-dh HARLECO k813427 12/31/1981
ultrachem enzymatic cholesterol oxidase EMD CHEMICALS INC. k823354 12/22/1982
twin star compartment pressure monitoring and fluid collection monitor (cms monitor) TWIN STAR MEDICAL k060963 06/06/2006
tsiii ba fixture OSSTEM IMPLANT Co., Ltd. k163088 04/21/2017
trapmatic system set H.S HOSPITAL SERVICE S.P.A. k033616 03/01/2004
transtek wrist blood pressure monitor Guangdong Transtek Medical Electronics Co., Ltd. k202599 12/06/2020

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