PMA P870007S010

Device: SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
Applicant: Optopics Laboratories Corp.
PMA number: P870007
Supplement: S010
Product code: LPN
Decision date: 1996-04-22
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR TRANSFER OF THE PROCESSING SITE FOR 100 PERCENT ETHYLENE OXIDE (ETO) STERILIZATION OF PLASTIC CONTAINERS, TIPS AND CLOSURES USED IN THE MANUFACTURE OF SORBIC ACID PRESERVED STERILE SALINE FOR SOFT CONTACT LENSES. THE ETO STERILIZATION FACILITY IS GRIFFITH MICROSCIENCE GLEN FALLS FACILITY, LOCATED IN GLEN FALLS, NY

Current openFDA PMA Record#

Device: SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
Applicant: Optopics Laboratories Corp.
PMA number: P870007
Supplement: S010
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1996-04-22
Decision code: APPR
Date received: 1995-10-03
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR TRANSFER OF THE PROCESSING SITE FOR 100 PERCENT ETHYLENE OXIDE (ETO) STERILIZATION OF PLASTIC CONTAINERS, TIPS AND CLOSURES USED IN THE MANUFACTURE OF SORBIC ACID PRESERVED STERILE SALINE FOR SOFT CONTACT LENSES. THE ETO STERILIZATION FACILITY IS GRIFFITH MICROSCIENCE GLEN FALLS FACILITY, LOCATED IN GLEN FALLS, NY