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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 K043503
Device Name VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
Applicant
VISX, INCORPORATED
3400 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051 -0703
Applicant Contact ALAN F RUSSELL
Correspondent
VISX, INCORPORATED
3400 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051 -0703
Correspondent Contact ALAN F RUSSELL
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/20/2004
Decision Date 04/05/2005
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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