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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameDURASOFT(R) TRUFOCAL(TM)
Classification Namelenses, soft contact, daily wear
Generic Namesoft contact lens (phemfilcon a)
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberN17852
Supplement NumberS008
Date Received07/22/1982
Decision Date04/20/1983
Product Code
LPL[ Registered Establishments with LPL ]
Notice Date 06/03/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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