MIRACLE-EAR MODEL PGC

MIRACLE-EAR MODEL PGC is an FDA 510(k)-cleared medical device (K942894) manufactured by Miracle-Ear/Dahlberg, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 16, 1994. Regulation: 8.