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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCUSTOMEYES(TM) 45L&55L (BUFILCON A)
Classification Namelenses, soft contact, daily wear
Generic Nametinted hydrophilic contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP850057
Date Received08/12/1985
Decision Date04/14/1986
Withdrawal Date 06/10/2009
Product Code
LPL[ Registered Establishments with LPL ]
Docket Number 86M-0184
Notice Date 07/01/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
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