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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-ZYME ENZYMATIC CLEANER
Classification Nameaccessories, soft lens products
Generic Namedaily protein remover (contact lens cleaner)
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP820001
Supplement NumberS021
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 alternate daily cleaner in the opti-soak(r) lens care regimen.
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