SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED

SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED is an FDA 510(k)-cleared medical device (K955680) manufactured by Mallinckrodt Medical. 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 12, 1996. Regulation: 8.