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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantUnited Contact Lens, Inc.
917-134th St. SW, #A-4
Everett, WA 98204
PMA NumberP870079
Supplement NumberS005
Date Received08/25/1989
Decision Date01/22/1990
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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