COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER

COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER is an FDA 510(k)-cleared medical device (K012955) manufactured by Bioform, 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 21, 2001. Regulation: 8.