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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantPACO PHARMACEUTICAL SERVICES, INC.
PMA NumberP850012
Supplement NumberS004
Date Received05/13/1988
Decision Date08/08/1988
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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