CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE

CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE is an FDA 510(k)-cleared medical device (K103303) manufactured by Crosstex International, 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 December 22, 2010. Regulation: 8.