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Tenacore Holdings, Inc.
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TENACORE OXYGEN BLENDER, MODEL TB-2000 is an FDA 510(k)-cleared medical device (K081335) manufactured by Tenacore Holdings, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 2008. Regulation: 8.