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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K133758
Device Name CENTERVUE MACULAR INTEGRITY ASSESSMENT
Applicant
Centervue S.P.A.
Piazza Albania 10
Rome,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
Centervue S.P.A.
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
HPT  
Date Received12/11/2013
Decision Date 04/23/2014
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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