DemeTECH PTFE Nonabsorbable Surgical Suture

DemeTECH PTFE Nonabsorbable Surgical Suture is an FDA 510(k)-cleared medical device (K181578) manufactured by Demetech Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2018. Regulation: 8.