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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 K890303
Device Name OPTI-TEARS(R)
Applicant
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Applicant Contact REBECCA G WALKER
Correspondent
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Correspondent Contact REBECCA G WALKER
Regulation Number886.5928
Classification Product Code
LPN  
Date Received01/23/1989
Decision Date 02/17/1989
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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