510(k) K963321

OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN by Custom Services Intl., Inc. — Product Code HIS

K963321 is an FDA 510(k) premarket notification submitted by Custom Services Intl., Inc. for the device "OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN". The FDA issued a decision of Substantially Equivalent on January 22, 1997. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Custom Services Intl., Inc. has at least 8 other 510(k) clearances on record.