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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K130289
Device Name TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
Applicant
TOPCON CORP.
5 TIMBER LANE
NORTH READING,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
TOPCON CORP.
5 TIMBER LANE
NORTH READING,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/05/2013
Decision Date 05/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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