TISSUEMEND SOFT TISSUE REPAIR MATRIX

TISSUEMEND SOFT TISSUE REPAIR MATRIX is an FDA 510(k)-cleared medical device (K020455) manufactured by Tei Biosciences, 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 April 2, 2002. Regulation: 8.