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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K943183
Device Name CIBA VISION(R) CONTACT LENS CASE
Applicant
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Applicant Contact CLAY DIXON
Correspondent
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Correspondent Contact CLAY DIXON
Regulation Number886.5928
Classification Product Code
LRX  
Date Received07/01/1994
Decision Date 08/04/1994
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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