CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT

CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT is an FDA 510(k)-cleared medical device (K121795) manufactured by Cytophil, 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 February 21, 2013. Regulation: 8.