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Rhythmlink International, LLC
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RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT is an FDA 510(k)-cleared medical device (K112435) manufactured by Rhythmlink International, LLC. 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 September 21, 2011. Regulation: 8.

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