510(k) K040282

ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAM

K040282 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID". The FDA issued a decision of Substantially Equivalent on April 29, 2004. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.