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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 NumberS008
Date Received11/03/1995
Decision Date07/10/1996
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE CLOSURE DESIGN WHICH UTILIZES A PIERCING CAP AND "FLIP-TOP" ON 12 OZ. AND 16 OZ. PRESERVED SLINE SOLUTION CONTAINERS ONLY
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