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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 NumberS009
Date Received10/17/1990
Decision Date03/28/1991
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
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