GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY

GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY is an FDA 510(k)-cleared medical device (K923488) manufactured by Applied Medical Technologies. 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 July 19, 1995. Regulation: 8.