COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE

COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE is an FDA 510(k)-cleared medical device (K032698) manufactured by Coapt Systems, Inc.. 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 October 22, 2003. Regulation: 8.