FINISHED METHAFILCON A CONTACT LENSES
FDA premarket approval P890049/S004 · decided 1998-05-29
Approval details
- PMA number
- P890049
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINISHED METHAFILCON A CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Lombart Lenses, Ltd.
- Date received
- 1998-05-07
- Decision date
- 1998-05-29
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Norfolk, VA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LL BI-FOCAL, DAILY WEAR CONTACT LENS (K971647) | Lombart Lenses, Ltd. | 1997-07-15 |
| SOFT-55 DAILY WEAR CONTACT LENS (K961428) | Lombart Lenses, Ltd. | 1996-05-21 |
| LL-55 (METHAFILCON A) FOR DAILY WEAR (K941877) | Lombart Lenses, Ltd. | 1994-06-14 |