PMA N18143

Device: FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION
Applicant: Alcon Laboratories
PMA number: N18143
Supplement: S033
Product code: LPN
Decision date: 1997-02-10
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOSE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES.

Current openFDA PMA Record

Device: FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION
Applicant: Alcon Laboratories
PMA number: N18143
Supplement: S033
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-02-10
Decision code: APPR
Date received: 1996-08-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOSE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES.