N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C is an FDA 510(k)-cleared medical device (K070168) manufactured by Aearo Company. 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 April 17, 2007. Regulation: 8.