DEFEND FLUID RESISTANT PLEATED MASK

DEFEND FLUID RESISTANT PLEATED MASK is an FDA 510(k)-cleared medical device (K971130) manufactured by Carl Parker Associates, 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 26, 1997. Regulation: 8.