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Inovel, LLC
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INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS is an FDA 510(k)-cleared medical device (K061859) 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 July 11, 2006. Regulation: 8.