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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-ONE(R) MULTI-PURPOSE SOLUTION
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP830034
Supplement NumberS029
Date Received07/31/1996
Decision Date11/21/1996
Product Code
LPN[ Registered Establishments with LPN ]
Docket Number N
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of opti-one(r) multi-purpose solution as a diluent for opti-zyme(r) enzymatic cleaner tablets.
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