PMA P860022S049
- Device
- IPAFLUOROFOCON A AND B
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S049
- Product code
- HQD
- Decision date
- 1998-02-06
- Classification
- Lens, Contact (other Material) - Daily
- Generic name
- Lens, contact (other material) - daily
- Approval order statement
- Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Wester Australia 60017.
Current openFDA PMA Record#
- Device
- IPAFLUOROFOCON A AND B
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S049
- Product code
- HQD
- Generic name
- Lens, contact (other material) - daily
- Decision date
- 1998-02-06
- Decision code
- APPR
- Date received
- 1997-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Wester Australia 60017.