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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 K993357
Device Name IOLMASTER
Applicant
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Applicant Contact SCOTT A MARGOLIN
Correspondent
CARL ZEISS, INC.
ONE ZEISS DR.
THORNWOOD,  NY  10594
Correspondent Contact SCOTT A MARGOLIN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received10/06/1999
Decision Date 03/20/2000
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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