GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT

GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT is an FDA 510(k)-cleared medical device (K864056) manufactured by Grieshaber & Co.. 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 30, 1986. Regulation: 8.