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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
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