HANAROSTENT BILIARY (NNN)

HANAROSTENT BILIARY (NNN) is an FDA 510(k)-cleared medical device (K111149) manufactured by M.I.Tech Co., Ltd.. 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 December 29, 2011. Regulation: 8.