
Argus Biomedical Pty, Ltd.
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ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) is an FDA 510(k)-cleared medical device (K013756) manufactured by Argus Biomedical Pty, Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2002. Regulation: 8.