GENTLE BACK, PLASTIC URINARY DRAINAGE BAG

GENTLE BACK, PLASTIC URINARY DRAINAGE BAG is an FDA 510(k)-cleared medical device (K861192) manufactured by Advanced Clinical Products, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 1986. Regulation: 8.