ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS

ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS is an FDA 510(k)-cleared medical device (K964909) manufactured by Xomed, 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 March 9, 1997. Regulation: 8.