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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameWEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namehydrophilic contact lens (tefilcon)
Regulation Number886.5925
ApplicantCIBA VISION CARE
PMA NumberP810005
Supplement NumberS022
Date Received07/17/1989
Decision Date08/08/1989
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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