510(k) K924406

CONVEEN(R) LEG BAG(500 ML) by Coloplast A/S — Product Code FAQ

K924406 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "CONVEEN(R) LEG BAG(500 ML)". The FDA issued a decision of Substantially Equivalent on October 30, 1992. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. Coloplast A/S has at least 10 other 510(k) clearances on record.