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Inovel, LLC
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INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A is an FDA 510(k)-cleared medical device (K063747) 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 January 11, 2007. Regulation: 8.