THE BLAIREX SYSTEM

FDA Premarket Approval P800028 S010

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.

Pre-market Approval Supplement Details

DeviceTHE BLAIREX SYSTEM
Generic NameAccessories, Soft Lens Products
ApplicantBLAIREX LABORATORIES, INC.
Date Received1983-12-21
Decision Date1984-05-25
PMAP800028
SupplementS010
Product CodeLPN 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address BLAIREX LABORATORIES, INC. 4810 Tecumseh Ln, p.o. Box 15190 evansville, IN 47716-0190

Supplemental Filings

Supplement NumberDateSupplement Type
P800028Original Filing
S015 1987-05-19 Normal 180 Day Track
S014 1987-04-20 Normal 180 Day Track
S013 1985-11-05
S012 1984-08-09
S011 1984-03-02
S010 1983-12-21
S009 1983-11-15
S008 1983-11-16
S007 1982-08-04
S006 1982-06-01
S005 1982-05-11
S004 1982-04-22
S003 1981-10-27
S002 1981-06-04
S001 1981-06-18

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