PMA P870007S009

Device: SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
Applicant: Optopics Laboratories Corp.
PMA number: P870007
Supplement: S009
Product code: LPN
Decision date: 1995-09-20
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR MODIFICATION OF THE STABILITY SPECIFICATIONS FOR SORBIC ACID CONCENTRATION FROM A RANGE OF 0.80 MG/ML - 1.20 MG/ML TO 0.70 MG/ML - 1.20 MG/ML

Current openFDA PMA Record#

Device: SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
Applicant: Optopics Laboratories Corp.
PMA number: P870007
Supplement: S009
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1995-09-20
Decision code: APPR
Date received: 1995-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATION OF THE STABILITY SPECIFICATIONS FOR SORBIC ACID CONCENTRATION FROM A RANGE OF 0.80 MG/ML - 1.20 MG/ML TO 0.70 MG/ML - 1.20 MG/ML