510(k) K895957

L.T.C. 1000 URINARY DRAINAGE BAG by Intl. Medical Marketing, Inc. — Product Code KNX

K895957 is an FDA 510(k) premarket notification submitted by Intl. Medical Marketing, Inc. for the device "L.T.C. 1000 URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Intl. Medical Marketing, Inc. has at least 4 other 510(k) clearances on record.