FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA

FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA is an FDA 510(k)-cleared medical device (K894176) manufactured by Precision Hearing Instruments. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 2, 1989. Regulation: 8.