SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES

SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES is an FDA 510(k)-cleared medical device (K904239) manufactured by Microbio-Medics, 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 June 20, 1991. Regulation: 8.