NOR-SA-TAB

FDA Premarket Approval P800069 S008

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

DeviceNOR-SA-TAB
Generic NameAccessories, Soft Lens Products
ApplicantAMCON, INC.
Date Received1986-06-18
Decision Date1986-12-04
PMAP800069
SupplementS008
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address AMCON, INC. 1102 Main St. p.o. Box 176 grandview, MO 64030

Supplemental Filings

Supplement NumberDateSupplement Type
P800069Original Filing
S009 1987-11-24 Special (immediate Track)
S008 1986-06-18 Normal 180 Day Track
S007 1985-05-24
S006 1985-04-16
S005
S004 1982-05-12
S003 1982-05-12
S002 1982-05-12
S001 1982-01-15

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