PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT
FDA premarket approval P850038/S018 · decided 1992-06-12
Approval details
- PMA number
- P850038
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Paragon Optical Co.
- Date received
- 1992-02-11
- Decision date
- 1992-06-12
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Mesa, AZ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CONTACT LENS MATERL (K811010) | Paragon Optical Co. | 1981-12-09 |