
Rockwin Corp.
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HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000 is an FDA 510(k)-cleared medical device (K935559) manufactured by Rockwin Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 26, 1994. Regulation: 8.

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