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Cook Biotech Incorprated
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BIODESIGN ENT REPAIR GRAFT is an FDA 510(k)-cleared medical device (K121360) manufactured by Cook Biotech Incorprated. 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 26, 2013. Regulation: 8.

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