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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 NameDURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberP850072
Supplement NumberS006
Date Received09/18/1989
Decision Date03/05/1990
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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