MANUAL IRRIGATING/ASPIRATING UNIT

MANUAL IRRIGATING/ASPIRATING UNIT is an FDA 510(k)-cleared medical device (K840495) manufactured by Alltek, 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 18, 1984. Regulation: 8.