
Bernafon, Inc.
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IN THE EAR MODEL X-ITE 84 is an FDA 510(k)-cleared medical device (K844985) manufactured by Bernafon, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 22, 1985. Regulation: 8.

Ansell
SKU MSC846624

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