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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K161457
Device Name XEN Glaucoma Treatment System
Applicant
Allergan, Inc.
26970 Aliso Viejo Pkwy., Suite 200
Aliso Viejo,  CA  92656
Applicant Contact Barbara A. Niksch
Correspondent
Allergan, Inc.
2525 Dupont Dr.
Mail Code T2-6l
Irvine,  CA  92612
Correspondent Contact Barbara A. Niksch
Regulation Number886.3920
Classification Product Code
KYF  
Date Received05/26/2016
Decision Date 11/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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