PMA P860022S048
- Device
- IPAFLUOROFOCON A AND B
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S048
- Product code
- HQD
- Decision date
- 1997-10-15
- Classification
- Lens, Contact (other Material) - Daily
- Generic name
- Lens, contact (other material) - daily
- Approval order statement
- Approval for the five additional finishing laboratories listed in the enclosure to become additional manufacturers and distributors of the contact lenses. FDA also acknowledges your notification of a new adopted USAN name for EQUALENS II (oprifocon A).
Current openFDA PMA Record#
- Device
- IPAFLUOROFOCON A AND B
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S048
- Product code
- HQD
- Generic name
- Lens, contact (other material) - daily
- Decision date
- 1997-10-15
- Decision code
- APPR
- Date received
- 1997-09-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- Approval for the five additional finishing laboratories listed in the enclosure to become additional manufacturers and distributors of the contact lenses. FDA also acknowledges your notification of a new adopted USAN name for EQUALENS II (oprifocon A).