
Starkey Laboratories, Inc.
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FEDELITY F495, VIENNATONE ALPP II is an FDA 510(k)-cleared medical device (K943687) manufactured by Starkey Laboratories, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 19, 1994. Regulation: 8.

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