PRO-PAK FOR OMS DIPLOMATE

PRO-PAK FOR OMS DIPLOMATE is an FDA 510(k)-cleared medical device (K950800) manufactured by M. Imonti and Associates 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 May 21, 1995. Regulation: 8.