O-PERM F60 RGP CONTACT LENS ADD FINISH LABS
FDA premarket approval P890046/S020 · decided 1993-09-20
Approval details
- PMA number
- P890046
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- O-PERM F60 RGP CONTACT LENS ADD FINISH LABS
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Optical Polymer Research, Inc.
- Date received
- 1993-05-21
- Decision date
- 1993-09-20
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gainesville, FL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| O-PERM 30 (K002703) | Optical Polymer Research, Inc. | 2000-11-21 |
| O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS (K954124) | Optical Polymer Research, Inc. | 1996-03-19 |