PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
FDA premarket approval P850038/S007 · decided 1989-12-27
Approval details
- PMA number
- P850038
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Paragon Optical Co.
- Date received
- 1989-05-15
- Decision date
- 1989-12-27
- Days to decision
- 226 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 |