STERILE SILICONE EXTERNAL WOUND COVER

STERILE SILICONE EXTERNAL WOUND COVER is an FDA 510(k)-cleared medical device (K982065) manufactured by Specialty Surgical Products, 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 August 11, 1998. Regulation: 8.