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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 St.
North Attleboro,  MA  02760
Applicant Contact BRIAN J EDWARDS
Correspondent
Massachusetts Eye & Ear Infirmary
49 Plain St.
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
Predetermined Change
Control Plan Authorized		 No
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