510(k) K964745

AMSINO URINARY DRAINAGE BAG by Amsino Intl., Inc. — Product Code KNX

K964745 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSINO URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on March 18, 1997. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.