AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)

AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) is an FDA 510(k)-cleared medical device (K073034) manufactured by Applied Medical Technology, Inc.. 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 March 13, 2008. Regulation: 8.