SILASTIC VOICE PROSTHESIS

SILASTIC VOICE PROSTHESIS is an FDA 510(k)-cleared medical device (K812864) manufactured by Dow Corning Corp. Healthcare Industries Materials. 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 November 23, 1981. Regulation: 8.