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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 K021143
Device Name OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
Applicant
Alcon Universal, Ltd.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact RALPH H LARSEN
Correspondent
Alcon Universal, Ltd.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Correspondent Contact RALPH H LARSEN
Regulation Number886.5928
Classification Product Code
LPN  
Date Received04/09/2002
Decision Date 08/08/2002
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
Recalls CDRH Recalls
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