PMA P890040S007

Device
SOF-FORM 55 EW, LL-55, SOFTCON EW 2
Applicant
Unilens Corp., USA
PMA number
P890040
Supplement
S007
Product code
LPM
Decision date
2013-08-06
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
DIRECT HYDRATION OF LENSES.

Current openFDA PMA Record#

Device
SOF-FORM 55 EW, LL-55, SOFTCON EW 2
Applicant
Unilens Corp., USA
PMA number
P890040
Supplement
S007
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2013-08-06
Decision code
OK30
Date received
2013-07-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
DIRECT HYDRATION OF LENSES.