IMPLANTECH MEDICAL GRADE SILICONE SHEETING

IMPLANTECH MEDICAL GRADE SILICONE SHEETING is an FDA 510(k)-cleared medical device (K944408) manufactured by King & Spalding. 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 8, 1994. Regulation: 8.