510(k) K063603

SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 by Suturtek Incorporated — Product Code GAQ

K063603 is an FDA 510(k) premarket notification submitted by Suturtek Incorporated for the device "SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17". The FDA issued a decision of Substantially Equivalent on February 7, 2007. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Suturtek Incorporated has at least 3 other 510(k) clearances on record.