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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-FREE REWETTING DROPS
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP830034
Supplement NumberS031
Date Received12/23/1996
Decision Date03/26/1997
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 for reducing the fill volume of opti-free(r) rewetting drops from the currently approved 5 ml to 3 ml in the same opaque low density polyethylene (ldpe) bottle.
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