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Dukal Corp.
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DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE is an FDA 510(k)-cleared medical device (K083320) manufactured by Dukal Corp.. 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 5, 2009. Regulation: 8.