
Resound Corp.
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RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE is an FDA 510(k)-cleared medical device (K891011) 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 March 28, 1989. Regulation: 8.

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