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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) CONTACT LNS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantKontur Kontact Lens Co., Inc.
642 Alfred Nobel Dr.
Hercules, CA 94547
PMA NumberP850078
Supplement NumberS001
Date Received10/02/1985
Decision Date06/25/1986
Withdrawal Date04/27/2015
Product Code LPL 
Docket Number 86M-0304
Notice Date 08/07/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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