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Kci USA, Inc.
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MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING is an FDA 510(k)-cleared medical device (K053627) manufactured by Kci USA, 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 February 5, 2006. Regulation: 8.