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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 K984573
Device Name OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
Applicant
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Applicant Contact RALPH H LARSEN
Correspondent
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Correspondent Contact RALPH H LARSEN
Regulation Number886.5928
Classification Product Code
LPN  
Date Received12/23/1998
Decision Date 09/16/1999
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
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