SEARE BIOMEDICAL SILICONE SHEETING

SEARE BIOMEDICAL SILICONE SHEETING is an FDA 510(k)-cleared medical device (K983041) manufactured by Seare Biomedical Corp.. 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 September 29, 1998. Regulation: 8.