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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 K121203
Device Name BOSTON KERATOPROSTHESIS OR BOSTON KPRO
Applicant
MASSACHUSETTS EYE & EAR INFIRMARY
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact BRIAN J EDWARDS
Correspondent
MASSACHUSETTS EYE & EAR INFIRMARY
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact BRIAN J EDWARDS
Regulation Number886.3400
Classification Product Code
HQM  
Date Received04/20/2012
Decision Date 05/10/2013
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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