KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000

KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 is an FDA 510(k)-cleared medical device (K853308) manufactured by Frigitronics of Connecticut, 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 October 3, 1985. Regulation: 8.