510(k) K000408

LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM by Suretex Prophylactics , Ltd. — Product Code HIS

K000408 is an FDA 510(k) premarket notification submitted by Suretex Prophylactics , Ltd. for the device "LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM". The FDA issued a decision of Substantially Equivalent on Apr 19, 2000. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.