P3 UNIVERSAL PHACO HANDPIECE

P3 UNIVERSAL PHACO HANDPIECE is an FDA 510(k)-cleared medical device (K972253) manufactured by Odyssey Technologies, 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 July 28, 1997. Regulation: 8.