510(k) K991191

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code GAM

K991191 is an FDA 510(k) premarket notification submitted by Genzyme Surgical Product (Genzyme Biosurgery) for the device "BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on June 22, 1999. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Genzyme Surgical Product (Genzyme Biosurgery) has at least 8 other 510(k) clearances on record.