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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K063583
Device Name ALCON VISION SYSTEM
Applicant
ALCON
6201 SOUTH FREEWAY, R7-20
FORT WORTH,  TX  76134 -2099
Applicant Contact TERRY J DAGNON
Correspondent
ALCON
6201 SOUTH FREEWAY, R7-20
FORT WORTH,  TX  76134 -2099
Correspondent Contact TERRY J DAGNON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/30/2006
Decision Date 05/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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