
Resound Corp.
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RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE is an FDA 510(k)-cleared medical device (K950319) manufactured by Resound Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 7, 1995. Regulation: 8.

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