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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 South Freeway
Fort Worth,  TX  76134 -2099
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
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