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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTERILE SALINE PRESERVED SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAutomatic Liquid Packaging, Inc.
2200 W. Lake Shore Dr.
Woodstock, IL 60098
PMA NumberP850070
Supplement NumberS010
Date Received06/04/1997
Decision Date07/02/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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