510(k) K913185

STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAQ

K913185 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT". The FDA issued a decision of Substantially Equivalent on December 4, 1991. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.