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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 K122418
Device Name IOLMASTER 500
Original Applicant
CARL ZEISS MEDITEC AG
5160 hacienda drive
dublin,  CA  94568
Original Contact judith a brimacombe
Regulation Number886.1850
Classification Product Code
HJO  
Date Received08/08/2012
Decision Date 04/12/2013
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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