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Moldex/Metric, Inc.
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MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS is an FDA 510(k)-cleared medical device (K062663) manufactured by Moldex/Metric, Inc.. 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 10, 2006. Regulation: 8.