VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K100950) manufactured by Venner Medical (Singapore) Pte, Ltd.. 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 12, 2010. Regulation: 8.