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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameENZYME/ SURFACTANT TABLET
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantSOLA OPTICAL USA, INC.
PMA NumberP880053
Supplement NumberS003
Date Received05/11/1989
Decision Date11/17/1989
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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