CAT. 3 GASTROENTEROLOGY-UROLOGY DEV

CAT. 3 GASTROENTEROLOGY-UROLOGY DEV is an FDA 510(k)-cleared medical device (K840307) manufactured by Imm Enterprises , Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 11, 1984. Regulation: 8.