510(k) K892529

REPRO-MED NEONATE ASPIRATION SYSTEM by Repro-Med Systems, Inc. — Product Code BSY

K892529 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. for the device "REPRO-MED NEONATE ASPIRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Repro-Med Systems, Inc. has at least 5 other 510(k) clearances on record.