510(k) K041511

TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE by Sutures India Private Limited — Product Code GAW

K041511 is an FDA 510(k) premarket notification submitted by Sutures India Private Limited for the device "TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Sutures India Private Limited has at least 4 other 510(k) clearances on record.