510(k) K100767

TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM by Church & Dwight Co., Inc. — Product Code MOL

K100767 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM". The FDA issued a decision of Substantially Equivalent on April 5, 2011. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.