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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameHYDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Generic Namesoft contact lenses
Regulation Number886.5925
ApplicantLES LABORATORIES BLONCHARD
PMA NumberP910029
Supplement NumberS001
Date Received06/15/1992
Decision Date06/29/1993
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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