DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY

DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY is an FDA 510(k)-cleared medical device (K840539) 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 March 8, 1984. Regulation: 8.