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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 K002589
Device Name OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
Applicant
Alcon Universal, Ltd.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact MICHAEL E PFLEGER
Correspondent
Alcon Universal, Ltd.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact MICHAEL E PFLEGER
Regulation Number886.5928
Classification Product Code
LPN  
Date Received08/21/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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