510(k) K192669

Extremely Thin 003, ZERO ZERO THREE by Okamoto USA, Inc. — Product Code HIS

K192669 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "Extremely Thin 003, ZERO ZERO THREE". The FDA issued a decision of Substantially Equivalent on July 24, 2020. 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.