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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
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
Jena,  DE 07445
Applicant Contact Christian Muenster
Biologics Consulting Group, Inc.
400 N. Washington Street, Suite 100
Alexandria,  VA  22314
Correspondent Contact Rahul Ram
Regulation Number886.1850
Classification Product Code
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