AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE is an FDA 510(k)-cleared medical device (K903694) manufactured by Amici, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 1990. Regulation: 8.