INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS

INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS is an FDA 510(k)-cleared medical device (K062665) manufactured by Inovel, LLC. 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 October 23, 2006. Regulation: 8.