INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS is an FDA 510(k)-cleared medical device (K961593) manufactured by Segi Hearing Aid Co.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 6, 1996. Regulation: 8.