K-TUBE REPAIR KIT

K-TUBE REPAIR KIT is an FDA 510(k)-cleared medical device (K840019) manufactured by Midwest Metabolic Support Group. 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 February 9, 1984. Regulation: 8.