510(k) K082828

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE by Suturtek Incorporated — Product Code GAQ

K082828 is an FDA 510(k) premarket notification submitted by Suturtek Incorporated for the device "SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on October 14, 2008. 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.