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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCOOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namepolymacon hydrophilic contact lenses
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP810057
Supplement NumberS005
Date Received04/12/1989
Decision Date06/22/1989
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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