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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 NumberS009
Date Received08/08/1995
Decision Date09/20/1995
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the stability specifications for sorbic acid concentration from a range of 0. 80 mg/ml - 1. 20 mg/ml to 0. 70 mg/ml - 1. 20 mg/ml.
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