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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSTERILE PRESERVED SALINE SOLUTION
Classification Nameaccessories, soft lens products
Generic Namelens solution
Regulation Number886.5928
ApplicantSTERIDYNE LABORATORIES, INC.
PMA NumberP890067
Supplement NumberS005
Date Received12/15/1993
Decision Date04/13/1994
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
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