STERILIZED FINISHED OCUFILCON B LENSES
FDA premarket approval P820051/S008 · decided 1988-09-19
Approval details
- PMA number
- P820051
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STERILIZED FINISHED OCUFILCON B LENSES
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Ocu-Ease Optical Products, Inc.
- Date received
- 1988-06-07
- Decision date
- 1988-09-19
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pinole, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.