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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K122404
Device Name MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
Applicant
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
24 CARPENTER RD
CHESTER,  NY  10918
Applicant Contact ANDREW I SEALFON
Correspondent
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
24 CARPENTER RD
CHESTER,  NY  10918
Correspondent Contact ANDREW I SEALFON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/07/2012
Decision Date 05/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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