ENTERA* ENTERAL FEEDING BAG

ENTERA* ENTERAL FEEDING BAG is an FDA 510(k)-cleared medical device (K881162) manufactured by Smash Ent., 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 June 2, 1988. Regulation: 8.