PMA N17974S048

Device: PREFLEX
Applicant: Alcon Laboratories
PMA number: N17974
Supplement: S048
Product code: LPN
Decision date: 1995-09-08
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR CHANGES IN MANUFACTURING PROCESS TO INCLUDE ELIMINIATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS

Current openFDA PMA Record

Device: PREFLEX
Applicant: Alcon Laboratories
PMA number: N17974
Supplement: S048
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1995-09-08
Decision code: APPR
Date received: 1995-08-16
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR CHANGES IN MANUFACTURING PROCESS TO INCLUDE ELIMINIATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS