510(k) K003712

MODIFICATION TO MALE TO MALE LUER ADAPTER by Molded Products, Inc. — Product Code KOC

K003712 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "MODIFICATION TO MALE TO MALE LUER ADAPTER". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Molded Products, Inc. has at least 6 other 510(k) clearances on record.