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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 NameKONTUR 55 EW
Classification Namelenses, soft contact, extended wear
Generic Name(methafilcon a) contact lens
Regulation Number886.5925
ApplicantKONTUR KONTACT LENS CO., INC.
PMA NumberP850078
Date Received10/30/1985
Decision Date01/31/1986
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 86M-0109
Notice Date 03/28/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S006 S007 
S008 S010 S012 S013 
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