AORP4000 REUSABLE PAK

AORP4000 REUSABLE PAK is an FDA 510(k)-cleared medical device (K931358) manufactured by American Optical Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 1994. Regulation: 8.