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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameUSE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP840066
Supplement NumberS034
Date Received11/20/1996
Decision Date01/23/1997
Product Code
LPN[ Registered Establishments with LPN ]
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 an alternate manufacturing site for the referenced device to be located at allergan optical, 8301 mars drive, waco, tx 76712.
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