OSEPT(R) & LENSEPT(R) SOLUTIONS
FDA premarket approval P820040/S030 · decided 1994-09-30
Approval details
- PMA number
- P820040
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OSEPT(R) & LENSEPT(R) SOLUTIONS
- Generic name
- Accessories, soft lens products
- Applicant
- Ciba Vision Care
- Date received
- 1991-09-03
- Decision date
- 1994-09-30
- Days to decision
- 1123 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROFESSIONAL DISINFECTION SYSTEM (PDS) (K863346) | Ciba Vision Care | 1987-02-27 |
| IN A WINK LUBRICATING & REWETTING DROPS (K853445) | Ciba Vision Care | 1985-11-29 |