PMA P830071S007
- Device
- OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392
- Applicant
- Alcon Laboratories
- PMA number
- P830071
- Supplement
- S007
- 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 DOESE 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
- OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392
- Applicant
- Alcon Laboratories
- PMA number
- P830071
- Supplement
- S007
- 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
- Approval order statement
- APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOESE 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.