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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 K222200
Device Name CIRRUS HD-OCT
Applicant
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublin,  CA  94568
Applicant Contact Vidita Desai
Correspondent
Carl Zeiss Meditec USA, Inc.
5300 Central Pkwy.
Dublin,  CA  94568
Correspondent Contact Tanesha Bland
Regulation Number886.1570
Classification Product Code
OBO  
Date Received07/25/2022
Decision Date 04/13/2023
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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