PMA P830034S031

Device: OPTI-FREE REWETTING DROPS
Applicant: Alcon Laboratories
PMA number: P830034
Supplement: S031
Product code: LPN
Decision date: 1997-03-26
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR REDUCING THE FILL VOLUME OF OPTI-FREE(R) REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME OPAQUE LOW DENSITY POLYETHYLENE (LDPE) BOTTLE.

Current openFDA PMA Record

Device: OPTI-FREE REWETTING DROPS
Applicant: Alcon Laboratories
PMA number: P830034
Supplement: S031
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-03-26
Decision code: APPR
Date received: 1996-12-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR REDUCING THE FILL VOLUME OF OPTI-FREE(R) REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME OPAQUE LOW DENSITY POLYETHYLENE (LDPE) BOTTLE.