ENDOVIEW SPPHIRE LENS SET

ENDOVIEW SPPHIRE LENS SET is an FDA 510(k)-cleared medical device (K971853) manufactured by American Medical Devices, 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 August 5, 1997. Regulation: 8.