GV3000 PHACOEMULSIFIER/FRAGMENTER

GV3000 PHACOEMULSIFIER/FRAGMENTER is an FDA 510(k)-cleared medical device (K883097) manufactured by D.O.R.C. Intl. B.V.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1988. Regulation: 8.