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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 NumberS006
Date Received05/12/1992
Decision Date04/14/1993
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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