METRO 55 (METHAFILCON A)
FDA premarket approval P830077/S002 · decided 1989-03-02
Approval details
- PMA number
- P830077
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METRO 55 (METHAFILCON A)
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Metrosoft, Inc.
- Date received
- 1988-10-28
- Decision date
- 1989-03-02
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Austin, TX
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC (K983021) | Metrosoft, Inc. | 1998-11-13 |
| METRO 55G TORIC & SPHERICAL (K953199) | Metrosoft, Inc. | 1995-12-11 |