VIVANT MEDICAL BIOPSY MARKER SYSTEM

VIVANT MEDICAL BIOPSY MARKER SYSTEM is an FDA 510(k)-cleared medical device (K000278) manufactured by Vivant Medical, 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 June 22, 2000. Regulation: 8.