BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES

BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES is an FDA 510(k)-cleared medical device (K062385) manufactured by Grace 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 26, 2006. Regulation: 8.