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Nexera Medical, Inc.
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SPECTRASHIELD 9500 SURGICAL MASK is an FDA 510(k)-cleared medical device (K090414) manufactured by Nexera Medical, 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 February 23, 2011. Regulation: 8.