DERMABOND PRINEO Skin Closure System

DERMABOND PRINEO Skin Closure System is an FDA 510(k)-cleared medical device (K163645) manufactured by Ethicon, LLC. 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 April 20, 2017. Regulation: 8.