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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP830034
Supplement NumberS028
Date Received08/16/1995
Decision Date09/08/1995
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the manufacturing process to eliminate air blowing of empty bottles and including specifications for control of particulate levels for bottles received from vendors.
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