
Cook Biotech Incorporated
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Biodesign Otologic Repair Graft is an FDA 510(k)-cleared medical device (K161000) manufactured by Cook Biotech Incorporated. 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 May 10, 2016. Regulation: 8.

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