XOMED-TREACE ALPHASCOPE

XOMED-TREACE ALPHASCOPE is an FDA 510(k)-cleared medical device (K923830) manufactured by Xomed-Treace, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 8, 1992. Regulation: 8.