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Kci USA, Inc. (Kinetic Concepts, Inc.)
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V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D is an FDA 510(k)-cleared medical device (K093526) 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 March 9, 2010. Regulation: 8.