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Entrigue Surgical, Inc.
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ENTACT SEPTAL STAPLER, MODEL 610-00100 is an FDA 510(k)-cleared medical device (K082750) manufactured by Entrigue Surgical, 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 January 5, 2009. Regulation: 8.