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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 K110489
Device Name SLIT LAMP SL-2G
Applicant
Topcon Medical Systems, Inc.
5 Timber Lane
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Topcon Medical Systems, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number886.1850
Classification Product Code
HJO  
Date Received02/22/2011
Decision Date 05/23/2011
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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