EPIFLO-28

EPIFLO-28 is an FDA 510(k)-cleared medical device (K190742) manufactured by Neogenix, LLC Dba Ogenix. 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 12, 2019. Regulation: 8.