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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 K925641
Device Name ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
Applicant
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/09/1992
Decision Date 09/09/1993
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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