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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 K101182
Device Name IOLMASTER 500
Applicant
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE
Correspondent
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568
Correspondent Contact JUDITH A BRIMACOMBE
Regulation Number886.1850
Classification Product Code
HJO  
Date Received04/27/2010
Decision Date 11/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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