POLLY'S CUTTER J-225

POLLY'S CUTTER J-225 is an FDA 510(k)-cleared medical device (K914038) 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 December 8, 1991. Regulation: 8.