REPROCESSED ENT SHAVERS

REPROCESSED ENT SHAVERS is an FDA 510(k)-cleared medical device (K081814) manufactured by Sterilmed, 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 December 16, 2008. Regulation: 8.