510(k) K911189

STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAW

K911189 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.