510(k) K902804

EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT by Okamoto USA, Inc. — Product Code HIS

K902804 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT". The FDA issued a decision of Substantially Equivalent on August 13, 1990. 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.