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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratoprosthesis, permanent implant
510(k) Number K013756
Device Name ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
Applicant
ARGUS BIOMEDICAL PTY LTD
3307 CLIFTON AVE.,
CINCINNATI,  OH  45220
Applicant Contact BARBARA S FANT
Correspondent
ARGUS BIOMEDICAL PTY LTD
3307 CLIFTON AVE.,
CINCINNATI,  OH  45220
Correspondent Contact BARBARA S FANT
Regulation Number886.3400
Classification Product Code
HQM  
Date Received11/13/2001
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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