MIRACLE-EAR IMPRESSION MATERIAL KIT

MIRACLE-EAR IMPRESSION MATERIAL KIT is an FDA 510(k)-cleared medical device (K942523) manufactured by Miracle-Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 22, 1994. Regulation: 8.