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Creative Contract (M) Sdn Bhd
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DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS is an FDA 510(k)-cleared medical device (K021539) manufactured by Creative Contract (M) Sdn Bhd. 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 4, 2003. Regulation: 8.