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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 K143275
FOIA Releasable 510(k) K143275
Device Name IOLMaster700
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin,  CA  94568 -7562
Applicant Contact Christine Dunbar
Carl Zeiss Meditec, Inc.
DUBLIN,  CA  94568 -7562
Correspondent Contact Christine Dunbar
Regulation Number886.1850
Classification Product Code
Date Received11/14/2014
Decision Date 07/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No