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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.
 
DeviceIGEL 67 CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantContamac, Ltd.
Orchard House
Bearwalden Business Park
Essex CB11-4JX
PMA NumberP860009
Supplement NumberS002
Date Received01/06/1989
Decision Date05/09/1989
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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