STELLARTECH 100 COAGULATION SYSTEM

STELLARTECH 100 COAGULATION SYSTEM is an FDA 510(k)-cleared medical device (K061544) manufactured by Stellartech Research Corp.. 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 October 12, 2006. Regulation: 8.