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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 K000385
Device Name OPTI-FREE EXPRESS LENS DROPS
Applicant
ALCON UNIVERSAL, LTD.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Applicant Contact RALPH H LARSEN
Correspondent
ALCON UNIVERSAL, LTD.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Correspondent Contact RALPH H LARSEN
Regulation Number886.5918
Classification Product Code
MRC  
Date Received02/07/2000
Decision Date 04/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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