
Kci USA, Inc. (Kinetic Concepts, Inc.)
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V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is an FDA 510(k)-cleared medical device (K160451) 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 June 19, 2016. Regulation: 8.