ACI SINGLE LUMEN BIOPSY NEEDLE

ACI SINGLE LUMEN BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K954264) manufactured by Advanced Cytometrix, 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 November 28, 1995. Regulation: 8.