
Cook Biotech, Inc.
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MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT is an FDA 510(k)-cleared medical device (K070405) 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 16, 2007. Regulation: 8.