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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 179 Results
ProductCode: FPA Applicant: Y Decision Date To: 01/18/2022
 
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infusion sets for single use Sichuan Prius Biotechnology Co., Ltd. K221075 11/21/2022
infusion sets for single use with needles Sichuan Prius Biotechnology Co., Ltd. K221069 11/21/2022
intravenous needles for single use,safety intravenous needles for single use Sichuan Prius Biotechnology Co., Ltd. K221078 11/21/2022
3m curos tamper-evident device, 3m curos tamper-evident device, large 3M Company K220507 05/23/2022
freedomedge syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K214045 04/29/2022
safety blood collection / infusion set (with/without needle holder), blood collection / infusion set (with/without needle holder) Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. K214075 04/12/2022
infusion sets for single use Jiangsu Suyun Medical Materials Co., Ltd. K202437 03/25/2022
bd vacutainer ultratouch push button blood collection set Becton, Dickinson and Company K212724 02/04/2022
freedom integrated syringe infusion system Repro-Med Systems, Inc., dba KORU Medical Systems K200176 12/15/2021
freedomedge(r) syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K211206 11/09/2021
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