About This 510(k) Submission
K181578 is an FDA 510(k) clearance for the DemeTECH PTFE Nonabsorbable Surgical Suture, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Demetech Corporation (Miami Lakes, US). The FDA issued a Cleared decision on October 11, 2018, 118 days after receiving the submission on June 15, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.