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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 K031957
Device Name MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
Original Applicant
CIBA VISION CORPORATION
11460 johns creek pkwy.
duluth,  GA  30097
Original Contact steven dowdley
Regulation Number886.5928
Classification Product Code
LPN  
Date Received07/21/2003
Decision Date 08/14/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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