MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM

MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K050347) manufactured by Endocare, 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 February 24, 2005. Regulation: 8.