IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

IRIS RETRACTING PHACOEMULSIFICATION SLEEVE is an FDA 510(k)-cleared medical device (K002812) manufactured by Michael Reynard, M.D.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2000. Regulation: 8.