510(k) K844401

REPRO-MED SYSTEMS INFUSION DEVICE by Repro-Med Systems, Inc. — Product Code FRN

K844401 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. for the device "REPRO-MED SYSTEMS INFUSION DEVICE". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Repro-Med Systems, Inc. has at least 5 other 510(k) clearances on record.