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Suturtek Incorporated
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SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE is an FDA 510(k)-cleared medical device (K082828) manufactured by Suturtek 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 October 13, 2008. Regulation: 8.