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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameSIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namehefilcon a contact lens
Regulation Number886.5925
ApplicantUNILENS CORP., USA
PMA NumberP850002
Supplement NumberS009
Date Received12/13/1991
Decision Date11/17/1993
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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