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U.S. Department of Health and Human Services

510(k) Premarket Notification
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121 to 130 of 185 Results
ProductCode: FPA Applicant: Y Decision Date To: 09/26/2016
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i.v. administration set MEDISYSTEMS CORP. K811837 07/10/1981
high-flo super26 subcutaneous needle sets Repro-Med Systems, Inc. dba RMS Medical Products K180843 04/04/2019
halo ii ambulatory infusion system (also with trade names nimbus ii ambulatory infusion system, evaa ambulatory infusion system) ZYNO MEDICAL LLC K153193 08/30/2016
halo ambulatory infusion system ZYNO MEDICAL LLC. K140783 10/17/2014
glucopro infusion set, model gpisxxxxxxxx series NIPRO DIABETES SYSTEMS, INC. K011120 05/08/2001
freedomedge(r) syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K211206 11/09/2021
freedomedge syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K214045 04/29/2022
freedom60 infusion pump; high-flo subcutaneous needle sets; precision flow rate tubing; high-flo super26 subcutaneous needle sets; freedom60 pre-filled syringe adapter Koru Medical Systems K231918 11/03/2023
freedom integrated syringe infusion system Repro-Med Systems, Inc., dba KORU Medical Systems K200176 12/15/2021
fluid administration set - contrast manager MERIT MEDICAL SYSTEMS, INC. K961794 08/01/1996
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