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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.
 
DeviceSORBIC ACID PRESERVED LENS LUBRICANT
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantPaco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood, NJ 08701
PMA NumberP850075
Supplement NumberS008
Date Received06/20/1990
Decision Date10/31/1990
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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