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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-CLEAN DAILY CLEANER
Classification Nameaccessories, soft lens products
Generic Namesoft lens cleaner
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP820036
Supplement NumberS013
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 include eliminating air blowing of empty bottles and including specifications for control of particulate levels for bottles received from vendors.
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