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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceENUCLENE CLEANING/LUBRICATING SOLUTION
Generic NameSolution, cleaning / lubricating, artificial eye
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberN13787
Date Received04/06/1964
Decision Date03/26/1997
Withdrawal Date 07/27/2012
Product Code MSI 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S003 
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