MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE

MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K896547) manufactured by Bivona Medical Technologies. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1990. Regulation: 8.