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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 K121555
Device Name CENTURION VISION SYSTEM
Applicant
ALCON LABORATORIES, INC.
15800 ALTON PARKWAY
IRVINE,  CA  92623
Applicant Contact CHARLES OGBONNA
Correspondent
ALCON LABORATORIES, INC.
15800 ALTON PARKWAY
IRVINE,  CA  92623
Correspondent Contact CHARLES OGBONNA
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/25/2012
Decision Date 12/21/2012
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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