510(k) K020659

DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT by Ssl Americas, Inc. — Product Code HIS

K020659 is an FDA 510(k) premarket notification submitted by Ssl Americas, Inc. for the device "DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT". The FDA issued a decision of Substantially Equivalent on March 29, 2002. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ssl Americas, Inc. has at least 10 other 510(k) clearances on record.