WestTec Procedure Facemask;WestTec Surgical Facemask

WestTec Procedure Facemask;WestTec Surgical Facemask is an FDA 510(k)-cleared medical device (K141085) manufactured by Westtec, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 2015. Regulation: 8.