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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 K172600
Device Name AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
Applicant
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact Martina Heim
Correspondent
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth,  TX  76134 -2099
Correspondent Contact Martina Heim
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/30/2017
Decision Date 10/25/2017
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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