BIOMARC PRELOADED TISSUE MARKER DEVICE

BIOMARC PRELOADED TISSUE MARKER DEVICE is an FDA 510(k)-cleared medical device (K042296) manufactured by Carbon Medical Technologies, 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 September 19, 2004. Regulation: 8.