EASY EYES (TM)

FDA Premarket Approval P830009 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

DeviceEASY EYES (TM)
Generic NameAccessories, Soft Lens Products
ApplicantEATON MEDICAL CORP.
Date Received1987-10-21
Decision Date1988-03-23
PMAP830009
SupplementS008
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address EATON MEDICAL CORP. 2288 Dunn Ave. memphis, TN 38114

Supplemental Filings

Supplement NumberDateSupplement Type
P830009Original Filing
S008 1987-10-21 Special (immediate Track)
S007 1984-05-22
S006 1984-05-07
S005 1984-02-14
S004 1984-02-14
S003 1983-11-22
S002 1983-10-07
S001 1983-09-30

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