BARRIER & FACE MASK WITH INNER FACING

BARRIER & FACE MASK WITH INNER FACING is an FDA 510(k)-cleared medical device (K791719) manufactured by Surgikos, 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 3, 1979. Regulation: 8.