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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 K874160
Device Name ZEISS 40 SL/P PHOTO SLIT LAMP
Applicant
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Applicant Contact VAN CADER
Correspondent
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Correspondent Contact VAN CADER
Regulation Number886.1850
Classification Product Code
HJO  
Date Received10/13/1987
Decision Date 01/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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