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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 K141068
Device Name ZEISS CATARACT SUITE MARKERLESS
Applicant
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568
Applicant Contact SARAH HARRINGTON
Correspondent
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568
Correspondent Contact SARAH HARRINGTON
Regulation Number886.1850
Classification Product Code
HJO  
Subsequent Product Codes
EPT   HMR   HRM   NFJ  
Date Received04/24/2014
Decision Date 09/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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