AMSURE FOLEY INSERTION TRAY

AMSURE FOLEY INSERTION TRAY is an FDA 510(k)-cleared medical device (K030664) manufactured by Amsino International, 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 May 22, 2003. Regulation: 8.