
Qualitone, Inc.
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THE CANAL (C.I.C.) AKA/HIDDEN EAR is an FDA 510(k)-cleared medical device (K941107) manufactured by Qualitone, 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 8, 1994. Regulation: 8.

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