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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameOTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI
Classification Namelenses, soft contact, daily wear
Generic Namepolymacon hydrogel contact lenses
Regulation Number886.5925
ApplicantOCULAR TECHNOLOGIES, INC.
PMA NumberP890031
Supplement NumberS003
Date Received03/14/1990
Decision Date04/25/1991
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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