
Cardinalhealth
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Kendall NPWT Incision Management Dressing Kit is an FDA 510(k)-cleared medical device (K191101) manufactured by Cardinalhealth. 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 July 30, 2020. Regulation: 8.