510(k) K964599

TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR by Line One Laboratories — Product Code HIS

K964599 is an FDA 510(k) premarket notification submitted by Line One Laboratories for the device "TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Line One Laboratories has at least 5 other 510(k) clearances on record.