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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.
 
DeviceTHE BLAIREX SYSTEM
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantBlairex Laboratories, Inc.
4810 Tecumseh Ln.,
P.O. Box 15190
Evansville, IN 47716
PMA NumberP800028
Supplement NumberS014
Date Received04/20/1987
Decision Date05/19/1987
Product Code LPN 
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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