
Cook Biotech Incorporated
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Biodesign Diaphragmatic Hernia Graft is an FDA 510(k)-cleared medical device (K171817) manufactured by Cook Biotech Incorporated. 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 March 12, 2018. Regulation: 8.