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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 K191650
Device Name LEGION System
Applicant
Alcon Research, LLC
6201 South Freeway
Fort Worth,  TX  76134
Applicant Contact Nickerson Hill
Correspondent
Alcon Research, LLC
6201 South Freeway
Fort Worth,  TX  76134
Correspondent Contact Nickerson Hill
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/20/2019
Decision Date 11/01/2019
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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