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Kepler Medtec
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KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE is an FDA 510(k)-cleared medical device (K110462) manufactured by Kepler Medtec. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2011. Regulation: 8.