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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSEREINE CLEANER,15ML NEW SAMPLE SIZE
Classification Nameaccessories, soft lens products
Generic Namergp lens cleaner
Regulation Number886.5928
ApplicantOPTIKEM INTERNATIONAL, INC.
PMA NumberP870050
Supplement NumberS003
Date Received11/19/1991
Decision Date01/28/1992
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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