BAG, LEG, URINE COLLECTING DEVICE

BAG, LEG, URINE COLLECTING DEVICE is an FDA 510(k)-cleared medical device (K760069) manufactured by Pharmaseal Div., Baxter Healthcare Corp.. 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 October 19, 1976. Regulation: 8.