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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCOMFORTCARE GP(R) WETTING AND SOAKING SOLUTION
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP820053
Supplement NumberS025
Date Received01/17/1997
Decision Date02/13/1997
Product Code
LPN[ Registered Establishments with LPN ]
Docket Number N
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 allergan, 8301 mars dr. , waco, tx 76712 as an alternate manufacturing site.
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