ACCUSEAL LEG BAGS & EXTENSION TUBES

ACCUSEAL LEG BAGS & EXTENSION TUBES is an FDA 510(k)-cleared medical device (K842396) manufactured by Convatec, A Division of E.R. Squibb & Sons. 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 August 7, 1984. Regulation: 8.