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Surgical Specialties Corp
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SHARPOINT PDO (POLYDIOXANONE) SUTURES is an FDA 510(k)-cleared medical device (K063680) manufactured by Surgical Specialties Corp. 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 May 8, 2007. Regulation: 8.