
Mitsui Textile Corp.
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HENRY SCHEIN SURGICAL MASK is an FDA 510(k)-cleared medical device (K992604) manufactured by Mitsui Textile Corp.. 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 27, 2000. Regulation: 8.