About This 510(k) Submission
K141007 is an FDA 510(k) clearance for the DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Demetech Corp. (Miami Lakes, US). The FDA issued a Cleared decision on September 25, 2014, 160 days after receiving the submission on April 18, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.