DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES is an FDA 510(k)-cleared medical device (K954989) manufactured by Smith & Nephew Dyonics, 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 November 26, 1995. Regulation: 8.