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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 K170171
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.
400 N. Washington Street, Suite 100
Alexandria,  VA  22314
Correspondent Contact Rahul Ram
Regulation Number886.1850
Classification Product Code
HJO  
Date Received01/19/2017
Decision Date 04/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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