510(k) K041510

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE by Sutures India Private Limited — Product Code GAR

K041510 is an FDA 510(k) premarket notification submitted by Sutures India Private Limited for the device "TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on June 2, 2005. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Sutures India Private Limited has at least 4 other 510(k) clearances on record.