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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameTRI POL 43 CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namesoft contact lens
Regulation Number886.5925
ApplicantGBF CONTACT LENSES, INC.
PMA NumberP780013
Supplement NumberS005
Date Received05/25/1989
Decision Date02/26/1991
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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