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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.
 
DeviceISOTONIC STERILE UNPRESERVED SALINE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantVisioncare Assoc.
480 S.
San Vicente Blvd.
Los Angeles, CA 90048
PMA NumberP860066
Supplement NumberS002
Date Received09/19/1988
Decision Date03/03/1989
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
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