TYTAN GROMMET VENT TUBE, .040

TYTAN GROMMET VENT TUBE, .040 is an FDA 510(k)-cleared medical device (K822366) manufactured by Treace Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 1982. Regulation: 8.