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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 K043222
Device Name VISCUCAM C DIGITAL CAMERA
Applicant
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568 -7562
Applicant Contact R. MICHAEL CROMPTON
Correspondent
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568 -7562
Correspondent Contact R. MICHAEL CROMPTON
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/22/2004
Decision Date 02/14/2005
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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