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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 K233902
Device Name Centurion™ Vision System (Active Sentry™) (8065753057)
Applicant
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth,  TX  76134
Applicant Contact De Rama Rita
Correspondent
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth,  TX  76134
Correspondent Contact De Rama Rita
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/11/2023
Decision Date 01/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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