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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 NameSOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)
Classification Namelenses, soft contact, daily wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberN17752
Supplement NumberS037
Date Received12/23/1999
Decision Date09/18/2000
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
Approval Order Statement 
Approval for the manufacturing facility located at wesley jessen, inc. , cidra, puerto rico.
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