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Cook Biotech, Inc.
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SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT is an FDA 510(k)-cleared medical device (K062697) manufactured by Cook Biotech, Inc.. 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 October 12, 2006. Regulation: 8.