LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT

LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT is an FDA 510(k)-cleared medical device (K893722) manufactured by Lori Medical Laboratories, 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 7, 1989. Regulation: 8.