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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Slit-Scanning
510(k) Number K191194
Device Name CLARUS
Applicant
Carl Zeiss Meditec, Inc
5160 Hacienda Drive
Dublin,  CA  94568
Applicant Contact Saurabh Jamkhindikar
Correspondent
Carl Zeiss Meditec, Inc
5160 Hacienda Drive
Dublin,  CA  94568
Correspondent Contact Saurabh Jamkhindikar
Regulation Number886.1120
Classification Product Code
QER  
Date Received05/03/2019
Decision Date 06/25/2019
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
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