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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
Classification Nameaccessories, soft lens products
Generic Namedaily protein remover (contact lens cleaner)
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP820001
Supplement NumberS023
Date Received06/12/1997
Decision Date07/03/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a 1. 5ml fill volume in the same container as the currently approved 3. 0ml fill size.
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