DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK

DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK is an FDA 510(k)-cleared medical device (K070692) manufactured by Dukal Corporation. 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 May 29, 2007. Regulation: 8.