510(k) K021019

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE by Genzyme Corp. — Product Code GAT

K021019 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE". The FDA issued a decision of Substantially Equivalent on June 18, 2002. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Genzyme Corp. has at least 10 other 510(k) clearances on record.