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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K162597
Device Name Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Applicant
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Sherri Lakota
Correspondent
Ciba Vision GmbH
Industriering 1
Grosswallstadt,  DE 63868
Correspondent Contact RALF FINKE
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
LRX  
Date Received09/19/2016
Decision Date 10/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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