
Genzyme Corp.
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COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE is an FDA 510(k)-cleared medical device (K021019) manufactured by Genzyme 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 June 17, 2002. Regulation: 8.