SAULFON PW-70 A&B
FDA premarket approval P840031/S008 · decided 1989-12-19
Approval details
- PMA number
- P840031
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SAULFON PW-70 A&B
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Lombart Lenses, Ltd.
- Date received
- 1989-07-19
- Decision date
- 1989-12-19
- Days to decision
- 153 days
- Decision code
- APPR
- 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 |