PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT is an FDA 510(k)-cleared medical device (K972815) manufactured by Grace Medical, 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 October 7, 1997. Regulation: 8.