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510(k) K013756

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) by Argus Biomedical Pty, Ltd. — Product Code HQM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 29, 2002
Date Received: November 13, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Keratoprosthesis, Permanent Implant
Device Class: Class II
Regulation Number: 886.3400
Review Panel: OP
Submission Type