FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS
FDA premarket approval P880001/S028 · decided 1991-03-18
Approval details
- PMA number
- P880001
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS
- Generic name
- Lens, contact (other material) - daily
- Applicant
- G.T. Laboratories, Inc.
- Date received
- 1990-09-06
- Decision date
- 1991-03-18
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chicago, IL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS (K991781) | G.T. Laboratories, Inc. | 1999-06-29 |
| FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C (K991780) | G.T. Laboratories, Inc. | 1999-06-29 |