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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 NameCUSTOMEYES(TM) 45L&55L (BUFILCON A)
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberP850057
Supplement NumberS005
Date Received05/15/1995
Decision Date09/22/1995
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing process using ultraviolet light initiator in the modified cure process for bufilcon a (55% water) contact lenses.
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