
Miracle-Ear, Inc.
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AUDIOTONE MODEL A-98 is an FDA 510(k)-cleared medical device (K926091) manufactured by Miracle-Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 11, 1993. Regulation: 8.

Ansell
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McKesson
SKU VM-1270030

Hollister
SKU VM-1270031