
Cook Biotech Incorporated
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Biodesign Parastomal Hernia Repair Graft is an FDA 510(k)-cleared medical device (K162934) 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 July 9, 2017. Regulation: 8.