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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameEPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES
Classification Namelenses, soft contact, daily wear
Generic Namesoft contact lenses
Regulation Number886.5925
ApplicantEPCON LABORATORIES
PMA NumberP880049
Supplement NumberS001
Date Received01/30/1991
Decision Date07/19/1991
Product Code
LPL[ Registered Establishments with LPL ]
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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