510(k) K180104

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant by Church & Dwight Co., Inc. — Product Code HIS

K180104 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant". The FDA issued a decision of Substantially Equivalent on March 14, 2018. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.