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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
Model RMS1-2406, RMS1-2409, RMS1-2412, RMS2-2406, RMS2-2409, RMS2-2412, RMS3-2406, RMS3-2409, RMS3-2412, RMS4-2406, RMS4-2409,
Device Name MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
Original Applicant
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
24 carpenter rd
chester,  NY  10918
Original Contact andrew i sealfon
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/07/2012
Decision Date 05/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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