510(k) K991892

TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR by Line One Laboratories — Product Code HIS

K991892 is an FDA 510(k) premarket notification submitted by Line One Laboratories for the device "TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR". The FDA issued a decision of Substantially Equivalent on August 19, 1999. 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.