PHACO NEEDLES 1000-R & 1000-O NEEDLES

PHACO NEEDLES 1000-R & 1000-O NEEDLES is an FDA 510(k)-cleared medical device (K923630) manufactured by O.R. Specialties, 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 April 5, 1994. Regulation: 8.