DURAHESIVE WAFER WITH FLANGE

DURAHESIVE WAFER WITH FLANGE is an FDA 510(k)-cleared medical device (K855018) manufactured by Convatec, A Division of E.R. Squibb & Sons. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 3, 1986. Regulation: 8.