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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 K161794
Device Name CENTURION Vision System (Active SentryTM)
Applicant
Alcon Research, Ltd.
6201 SOUTH FREEWAY DR.
FORT WORTH,  TX  76134 -2099
Applicant Contact Paul Swift
Correspondent
Alcon Research, Ltd.
6201 SOUTH FREEWAY DR.
FORT WORTH,  TX  76134 -2099
Correspondent Contact Paul Swift
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/30/2016
Decision Date 04/14/2017
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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