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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 K120912
Device Name INFINITI(R) VISION SYSTEM
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 Received03/26/2012
Decision Date 06/15/2012
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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