510(k) K052959

DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS by Ssl Americas — Product Code HIS

K052959 is an FDA 510(k) premarket notification submitted by Ssl Americas for the device "DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS". The FDA issued a decision of Substantially Equivalent on January 27, 2006. 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.