FOLEY INSERTION TRAYS W/OVERWRAY

FOLEY INSERTION TRAYS W/OVERWRAY is an FDA 510(k)-cleared medical device (K820987) manufactured by Inmed 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 May 12, 1982. Regulation: 8.