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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 K112425
Device Name INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
Applicant
Alcon Manufacturing, Ltd.
15800 Alton Pkwy.
Irvine,  CA  92618 -3818
Applicant Contact MARTIN A KAUFMAN
Correspondent
Alcon Manufacturing, Ltd.
15800 Alton Pkwy.
Irvine,  CA  92618 -3818
Correspondent Contact MARTIN A KAUFMAN
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQR   KYB   MLZ  
Date Received08/23/2011
Decision Date 11/21/2011
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
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