510(k) K042957

DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT by Ssl Americas — Product Code HIS

K042957 is an FDA 510(k) premarket notification submitted by Ssl Americas for the device "DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT". The FDA issued a decision of Substantially Equivalent on February 17, 2005. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ssl Americas has at least 10 other 510(k) clearances on record.