ECKHARDT TEMPORARY KERATOPROSTHESIS

ECKHARDT TEMPORARY KERATOPROSTHESIS is an FDA 510(k)-cleared medical device (K902491) manufactured by Dutch Ophthalmic USA, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1990. Regulation: 8.