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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K133217
Device Name CIRRUS PHOTO
Applicant
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact MANDY AMBRECHT
Correspondent
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact MANDY AMBRECHT
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HKI  
Date Received10/18/2013
Decision Date 03/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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