About This 510(k) Submission
K082828 is an FDA 510(k) clearance for the SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Suturtek Incorporated (Acton, US). The FDA issued a Cleared decision on October 14, 2008, 19 days after receiving the submission on September 25, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.