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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
Model TYPE I OR TYPE II
Device Name BOSTON KERATOPROSTHESIS OR BOSTON KPRO
Applicant
MASSACHUSETTS EYE & EAR INFIRMARY
49 plain street
north attleboro,  MA  02760
Contact brian j edwards
Regulation Number886.3400
Classification Product Code
HQM  
Date Received04/20/2012
Decision Date 05/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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