TRACHEOSTOMY CARE KIT

TRACHEOSTOMY CARE KIT is an FDA 510(k)-cleared medical device (K952416) manufactured by Medi-Flex Hospital Products, 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 August 8, 1995. Regulation: 8.