CONVATEC FECAL MANAGEMENT SYSTEM

CONVATEC FECAL MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K032734) manufactured by Convatec, A Bristol-Myers Squibb Co.. 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 7, 2004. Regulation: 8.