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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 K083812
Device Name REFRESH OPTIVE LENS COMFORT REWETTING DROPS
Original Applicant
ALLERGAN, INC.
269a ballardvale street
wilmington,  MA  01887
Original Contact beverley d venuti
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received12/22/2008
Decision Date 07/09/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
summary summary
Type Traditional
Clinical Trials NCT00691197
Reviewed by Third Party No
Combination Product No
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