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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 K141481
Device Name TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
Applicant
Topcon Corporation
5 Timber Ln.
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Topcon Corp.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/04/2014
Decision Date 09/17/2014
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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