TRACHEOSTOMY CARE KIT (STERILE)

TRACHEOSTOMY CARE KIT (STERILE) is an FDA 510(k)-cleared medical device (K925020) manufactured by Customed, 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 July 6, 1993. Regulation: 8.