SAUFLON MULTI LENS CARE SYSTEM
FDA 510(k) clearance K010559 · decided 2001-12-20
Clearance details
- K-number
- K010559
- Device name
- SAUFLON MULTI LENS CARE SYSTEM
- Applicant
- Sauflon Pharmaceuticals, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-26
- Decision date
- 2001-12-20
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Twickenham, Middlesex, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hy recall (Z-0379-04) | CVS | 2004-07-20 |