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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K180526
Device Name EIDON FA
Applicant
Centervue S.P.A.
Via S. Marco 9h
Padova,  IT 35129
Applicant Contact Roberto Gabriotti
Correspondent
Centervue S.P.A.
Via S. Marco 9h
Padova,  IT 35129
Correspondent Contact Roberto Gabriotti
Regulation Number886.1570
Classification Product Code
MYC  
Subsequent Product Code
HKI  
Date Received02/27/2018
Decision Date 07/16/2018
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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