
Cook Biotech Incorprated
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Biodesign Enterocutaneous Fistula Plug is an FDA 510(k)-cleared medical device (K150668) manufactured by Cook Biotech Incorprated. 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 December 8, 2015. Regulation: 8.