510(k) K140379

MEGA BIG BOY CONDOM by Okamoto USA, Inc. — Product Code HIS

K140379 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "MEGA BIG BOY CONDOM". The FDA issued a decision of Substantially Equivalent on July 1, 2014. 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.