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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.
 
DeviceCHARTER LABS SALINE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantPaco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood, NJ 08701
PMA NumberP840069
Supplement NumberS004
Date Received08/31/1987
Decision Date04/01/1988
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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