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U.S. Department of Health and Human Services

510(k) Premarket Notification

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101 to 110 of 176 Results
ProductCode: FPA Applicant: Y Decision Date To: 01/18/2022
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glucopro infusion set, model gpisxxxxxxxx series NIPRO DIABETES SYSTEMS, INC. K011120 05/08/2001
sterile i.v. start kit ORION LIFE SYSTEMS, INC. K902810 11/13/1990
infusion sets #'s 124 & 142 personal PACESETTER SYSTEMS K831445 09/12/1983
samuels - micro -scler catheter POLYVAL, INC. K891164 06/23/1989
phaseal, system for sealed handling of chemotherapeutic agents QUALITY SYSTEM CONSULTING K972527 09/18/1997
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
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