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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 K123460
Device Name TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
Applicant
TOPCON MEDICAL SYSTEMS, INC.
111 BAUER DR
OAKLAND,  NJ  07436
Applicant Contact MICHAEL GUSEL
Correspondent
TOPCON MEDICAL SYSTEMS, INC.
111 BAUER DR
OAKLAND,  NJ  07436
Correspondent Contact MICHAEL GUSEL
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/09/2012
Decision Date 02/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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