
Kci USA, Inc. (Kinetic Concepts, Inc.)
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PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is an FDA 510(k)-cleared medical device (K161897) manufactured by Kci USA, Inc. (Kinetic Concepts, 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 October 3, 2016. Regulation: 8.