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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 NameTORAY SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namesoft contact lenses
Regulation Number886.5925
ApplicantTORAY INDUSTRIES (AMERICA), INC.
PMA NumberP840044
Supplement NumberS002
Date Received12/18/1989
Decision Date02/01/1990
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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