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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceENUCLENE(R) OPHTHALMIC SOLUTION
Classification Namesolution, cleaning/lubricating, artifical eye
Generic Namesolution, cleaning/lubricating, artifical eye
Applicant
Alcon Research, Ltd.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberN13787
Supplement NumberS003
Date Received10/25/1999
Decision Date12/10/1999
Product Code
MSI[ Registered Establishments with MSI ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alternate manufacturing facility located at alcon laboratories, inc. , aspex manufacturing facility, 6201 south freeway, fort worth, tx 76134.
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