OP-3 (TM) RGP CONTACT LENS
FDA premarket approval P920045/S001 · decided 1994-02-24
Approval details
- PMA number
- P920045
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- OP-3 (TM) RGP CONTACT LENS
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Stellar Contact Lens, Inc.
- Date received
- 1994-01-27
- Decision date
- 1994-02-24
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Skokie, IL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) (K952260) | Stellar Contact Lens, Inc. | 1996-01-03 |