XOMED-TREACE SCOPESHEATH

XOMED-TREACE SCOPESHEATH is an FDA 510(k)-cleared medical device (K933672) manufactured by Xomed-Treace, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 1994. Regulation: 8.