510(k) K001434

'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code GAT

K001434 is an FDA 510(k) premarket notification submitted by Genzyme Surgical Product (Genzyme Biosurgery) for the device "'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE". The FDA issued a decision of SN on June 12, 2000. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Genzyme Surgical Product (Genzyme Biosurgery) has at least 8 other 510(k) clearances on record.