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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, Ac-Powered
510(k) Number K052268
Device Name VISUCAM PRO NM
Applicant
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact KENT W JONES
Correspondent
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact KENT W JONES
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/19/2005
Decision Date 11/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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