PUREGRAFT 850/PURE SYSTEM

PUREGRAFT 850/PURE SYSTEM is an FDA 510(k)-cleared medical device (K113255) manufactured by Cytori Therapeutics, 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 March 6, 2012. Regulation: 8.