BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II is an FDA 510(k)-cleared medical device (K992872) manufactured by Entific Medical Systems, 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 November 23, 1999. Regulation: 8.