510(k) K041514

TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE by Sutures India Private Limited — Product Code GAP

K041514 is an FDA 510(k) premarket notification submitted by Sutures India Private Limited for the device "TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Sutures India Private Limited has at least 4 other 510(k) clearances on record.