VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA is an FDA 510(k)-cleared medical device (K100780) manufactured by Unilene Sac. 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 December 13, 2010. Regulation: 8.