
Bernafon-Maico, Inc.
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OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) is an FDA 510(k)-cleared medical device (K974152) manufactured by Bernafon-Maico, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 14, 1997. Regulation: 8.

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