510(k) K884401

SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT by Okamoto USA, Inc. — Product Code HIS

K884401 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT". The FDA issued a decision of Substantially Equivalent on January 12, 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.