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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 K133476
Device Name SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
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  
Date Received11/12/2013
Decision Date 02/12/2014
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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