
Genzyme Surgical Product (Genzyme Biosurgery)
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'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE is an FDA 510(k)-cleared medical device (K001434) manufactured by Genzyme Surgical Product (Genzyme Biosurgery). 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 June 11, 2000. Regulation: 8.