SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR

SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR is an FDA 510(k)-cleared medical device (K120244) 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 July 4, 2012. Regulation: 8.