
Bivona Medical Technologies
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PERISCOPE VOICE PROSTHESIS is an FDA 510(k)-cleared medical device (K820737) manufactured by Bivona Medical Technologies. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 1982. Regulation: 8.

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