NAVARRE 600 ML DRAINAGE BAG

NAVARRE 600 ML DRAINAGE BAG is an FDA 510(k)-cleared medical device (K943663) manufactured by Navarre Biomedical , Ltd.. 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 September 7, 1994. Regulation: 8.