510(k) K072169

DUREX SYNTHETIC POLYISOPRENE MALE CONDOM by Ssl Americas, Inc. — Product Code MOL

K072169 is an FDA 510(k) premarket notification submitted by Ssl Americas, Inc. for the device "DUREX SYNTHETIC POLYISOPRENE MALE CONDOM". The FDA issued a decision of Substantially Equivalent on June 19, 2008. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Ssl Americas, Inc. has at least 10 other 510(k) clearances on record.