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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameFLEXENS (HEFILCON A) SOFT CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namesoft contact lens
Regulation Number886.5925
ApplicantPARAGON VISION SCIENCES
PMA NumberN17976
Supplement NumberS010
Date Received02/09/1990
Decision Date07/12/1990
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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