MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT

MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT is an FDA 510(k)-cleared medical device (K903878) manufactured by Mentor O & O, 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 November 4, 1990. Regulation: 8.