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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 K173771
Device Name IOLMaster 700
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07445
Applicant Contact Christian Muenster
Correspondent
Biologics Consulting Group, Inc.
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Lisa Graney
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/11/2017
Decision Date 08/24/2018
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
Recalls CDRH Recalls
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