510(k) K970767

CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH by Custom Services Intl., Inc. — Product Code HIS

K970767 is an FDA 510(k) premarket notification submitted by Custom Services Intl., Inc. for the device "CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH". The FDA issued a decision of Substantially Equivalent on June 2, 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.