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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Polymethylmethacrylate)
510(k) Number K853445
Device Name IN A WINK LUBRICATING & REWETTING DROPS
Applicant
Ciba Vision Care
2910 Amwiler Ct.
Atlanta,  GA  30360
Applicant Contact PAUL G STAPLETON
Correspondent
Ciba Vision Care
2910 Amwiler Ct.
Atlanta,  GA  30360
Correspondent Contact PAUL G STAPLETON
Classification Product Code
HPX  
Date Received08/16/1985
Decision Date 11/29/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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