SHILEY SPECIALIZED TRACHEOSTOMY TUBE

SHILEY SPECIALIZED TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K903435) manufactured by Shiley, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 1990. Regulation: 8.