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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceKONTUR SOFT (METHAFILCON A) LENS
Classification Namelenses, soft contact, daily wear
Generic Namelenses, soft contact, daily wear
Regulation Number886.5925
Applicant
KONTUR KONTACT LENS CO., INC.
642 alfred nobel dr.
hercules, CA 94547
PMA NumberP850078
Supplement NumberS003
Date Received03/05/1987
Decision Date09/28/1987
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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