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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K001235
Device Name OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
Applicant
ALCON UNIVERSAL, LTD.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Applicant Contact RALPH H LARSON
Correspondent
ALCON UNIVERSAL, LTD.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Correspondent Contact RALPH H LARSON
Regulation Number886.5918
Classification Product Code
MRC  
Date Received04/17/2000
Decision Date 07/03/2000
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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