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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 K142284
Device Name CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
Applicant
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,,  TX  76134
Applicant Contact ALICIA PLESNARSKI
Correspondent
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,,  TX  76134
Correspondent Contact ALICIA PLESNARSKI
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received08/18/2014
Decision Date 01/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01912768
NCT01912781
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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