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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K161972
Device Name Slit Lamp SL-D301
Applicant
Topcon Corporation
75-1 Hasunuma-Cho, Itabashil-Ku
Tokyo,  JP 174-8580
Applicant Contact MICHAEL GUSEL
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number886.1850
Classification Product Code
HJO  
Date Received07/18/2016
Decision Date 12/09/2016
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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