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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 NameFRESHLOOK COLORS UV AND FRESHLOOK LITETINT UV (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberP830037
Supplement NumberS039
Date Received10/02/1995
Decision Date01/25/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for incorporating an ultra-violet absorber into the device.
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