510(k) K102512

RMS SUBCUTANEOUS NEEDLE SET by Repro-Med Systems, Inc. — Product Code FPA

K102512 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. for the device "RMS SUBCUTANEOUS NEEDLE SET". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Repro-Med Systems, Inc. has at least 5 other 510(k) clearances on record.