510(k) K122404

MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 by Repro-Med Systems, Inc. Dba Rms Medical Products — Product Code FPA

K122404 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. Dba Rms Medical Products for the device "MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26". The FDA issued a decision of Substantially Equivalent on May 6, 2013. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Repro-Med Systems, Inc. Dba Rms Medical Products has 2 other 510(k) clearances on record.