CYTORI PUREGRAFT 250/PURE SYSTEM

CYTORI PUREGRAFT 250/PURE SYSTEM is an FDA 510(k)-cleared medical device (K092923) 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 January 5, 2010. Regulation: 8.