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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 NumberS010
Date Received06/04/1997
Decision Date07/02/1997
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 
Approval to eliminate ethylene oxide sterilization of the flip-top piercing cap attached to sealed 12 oz. And 16 oz. Containers of sterile preserved saline solution.
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