510(k) K041048

POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE by Internacional Farmaceutica, S.A. DE C.V. — Product Code NEW

K041048 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on June 4, 2004. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.