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U.S. Department of Health and Human Services

510(k) Premarket Notification
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111 to 120 of 185 Results
ProductCode: FPA Applicant: Y Decision Date To: 03/24/2017
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rms subcutaneous needle set REPRO-MED SYSTEMS, INC. K102512 05/20/2011
high-flo super26 subcutaneous needle sets Repro-Med Systems, Inc. dba RMS Medical Products K180843 04/04/2019
model number: rms1-2604, rms1-2614, rms1-2404, rms1-2414, rms2-2604, rms2-2614, rms2-2404, rms2-2414, rms3-2604, rms3-26 REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS K122404 05/06/2013
freedom integrated syringe infusion system Repro-Med Systems, Inc., dba KORU Medical Systems K200176 12/15/2021
integrated catch-up freedom syringe driver infusion system Repro-Med Systems, Inc., DBA RMS Medical Products K162613 08/31/2017
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
vortex ct port access system and lifeguard safety infusion set RITA MEDICAL SYSTEMS, INC. K062414 02/01/2007
safety injection port, modification RIVERSIDE TECHNOLOGY, INC. K913311 09/13/1991
saf-t clik i.v. in-line connector & extension set RYAN MEDICAL, INC. K901729 06/18/1990
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