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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392
Classification Nameaccessories, soft lens products
Generic Namewetting, soaking, and disisfec. solut.
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP830071
Supplement NumberS009
Date Received03/04/1997
Decision Date03/19/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification in the package insert to include addition of the following statement in the directions sections: "you may store your lenses in the unopened case until ready to wear, up to a maximum of thirty days. If your lenses are stored for longer periods of time, they must be cleaned and disinfected with fresh solution every thirty days and prior to wear. ".
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