IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE is an FDA 510(k)-cleared medical device (K862188) manufactured by Coburn Optical Ind., 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 20, 1986. Regulation: 8.