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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K160609
Device Name AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
Applicant
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Alicia M. Plesnarski
Correspondent
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Alicia M. Plesnarski
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/03/2016
Decision Date 05/02/2016
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
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