510(k) K911354

STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAL

K911354 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES". The FDA issued a decision of Substantially Equivalent on October 25, 1991. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.