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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-FREE SUPRACLENS
Classification Nameaccessories, soft lens products
Generic Namedaily protein remover (contact lens cleaner)
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP820001
Supplement NumberS022
Date Received03/04/1997
Decision Date07/02/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to allow for the use of alcon multi-purpose solution id 81573 (opti-one multi-purpose solution) as an alternate diluent for opti-free(r) supraclens(r) daily protein remover.
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