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Interacoustics AS
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AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS is an FDA 510(k)-cleared medical device (K043219) manufactured by Interacoustics AS. 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 February 3, 2005. Regulation: 8.

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