510(k) K884402

EXTRA STRENGTH SKIN LESS SKIN CONDOM by Okamoto USA, Inc. — Product Code HIS

K884402 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "EXTRA STRENGTH SKIN LESS SKIN CONDOM". The FDA issued a decision of Substantially Equivalent on March 10, 1989. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Okamoto USA, Inc. has at least 10 other 510(k) clearances on record.