510(k) K041515

TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE by Sutures India Private Limited — Product Code GAM

K041515 is an FDA 510(k) premarket notification submitted by Sutures India Private Limited for the device "TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on April 8, 2005. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Sutures India Private Limited has at least 4 other 510(k) clearances on record.