CHROMOPHARE E 668

CHROMOPHARE E 668 is an FDA 510(k)-cleared medical device (K090378) manufactured by Berchtold GmbH & Co. KG. 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 February 22, 2009. Regulation: 8.