510(k) K013671

L-25 ABSORBABLE SURIGCAL SUTURE by United States Surgical, A Division of Tyco Healthc — Product Code GAM

K013671 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "L-25 ABSORBABLE SURIGCAL SUTURE". The FDA issued a decision of Substantially Equivalent on January 8, 2002. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.