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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSORBIC ACID PRESERVED SALINE SOL.PH CHANGE
Classification Nameaccessories, soft lens products
Generic Namesterile preserved saline solution
Regulation Number886.5928
ApplicantOPTOPICS LABORATORIES CORP.
PMA NumberP870007
Supplement NumberS010
Date Received10/03/1995
Decision Date04/22/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for transfer of the processing site for 100 percent ethylene oxide (eto) sterilization of plastic containers, tips and closures used in the manufacture of sorbic acid preserved sterile saline for soft contact lenses. The eto sterilization facility is griffith microscience glen falls facility, located in glen falls, ny.
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