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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.
 
Trade NameENUCLENE(R) OPHTHALMIC SOLUTION
Classification Namesolution, cleaning/lubricating, artifical eye
ApplicantALCON LABORATORIES
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 location change: manufacturer
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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