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U.S. Department of Health and Human Services

510(k) Premarket Notification

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51 to 60 of 185 Results
ProductCode: FPA Applicant: Y Decision Date To: 01/22/2017
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extension set WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) K896561 02/01/1990
extension set w/injection site MEDFUSION SYSTEMS, INC. K842984 10/16/1984
extension sets with and without filters MEDICAL SUPPORT SYSTEMS K890176 04/26/1989
ez administration set Y K931550 01/10/1994
female luer lock cap MedSafety Solutions LLC K200425 10/29/2020
fluid administration set - contrast manager MERIT MEDICAL SYSTEMS, INC. K961794 08/01/1996
freedom integrated syringe infusion system Repro-Med Systems, Inc., dba KORU Medical Systems K200176 12/15/2021
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
freedomedge syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K214045 04/29/2022
freedomedge(r) syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K211206 11/09/2021
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