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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameALCON 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 NumberS008
Date Received12/18/1996
Decision Date05/15/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for (1) use of opti-soak(r) conditioning solution as an alternate diluent for opti-free(r) supraclens(tm) daily protein remover, (2) to expand the indications for use of opti-free(r) supraclens(tm) to allow for use with rigid gas permeable (rgp) contact lenses, and (3) for use of opti-clean(r) ii daily cleaner as an alterante daily cleaner in the opti-soak(r) lens care regimen.
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