510(k) K052482

ARTELON SURGICAL SUTURE by Artimplant AB — Product Code GAR

K052482 is an FDA 510(k) premarket notification submitted by Artimplant AB for the device "ARTELON SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on October 17, 2005. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Artimplant AB has at least 6 other 510(k) clearances on record.