DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 is an FDA 510(k)-cleared medical device (K102409) manufactured by Byrne Medical, 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 November 3, 2010. Regulation: 8.