NOVOPORE DRESSING

NOVOPORE DRESSING is an FDA 510(k)-cleared medical device (K132936) manufactured by Polynovo Biomaterials Pty, Ltd.. 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 March 3, 2014. Regulation: 8.