PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES

PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES is an FDA 510(k)-cleared medical device (K972478) 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 February 8, 1998. Regulation: 8.