
Stellartech Research Corp.
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MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 is an FDA 510(k)-cleared medical device (K032452) 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 August 20, 2003. Regulation: 8.