REGEN COLLAGEN SCAFFOLD (CS)

REGEN COLLAGEN SCAFFOLD (CS) is an FDA 510(k)-cleared medical device (K082079) manufactured by Regen Biologics, 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 December 17, 2008. Regulation: 8.