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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSTERILE SALINE PRESERVED SOLUTION
Classification Nameaccessories, soft lens products
Generic Namesterile saline solution
Regulation Number886.5928
ApplicantAUTOMATIC LIQUID PACKAGING, INC.
PMA NumberP850070
Supplement NumberS009
Date Received02/14/1997
Decision Date06/20/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of ethylene oxide sterilization of the piercing cap attached to sealed 12 oz. And 16 oz. Containers of sterile preserved saline solution.
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