
Fisma, Inc.
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ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV is an FDA 510(k)-cleared medical device (K990174) manufactured by Fisma, 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 31, 1999. Regulation: 8.