OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
FDA 510(k) clearance K021143 · decided 2002-08-08
Clearance details
- K-number
- K021143
- Device name
- OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
- Applicant
- Alcon Universal, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-09
- Decision date
- 2002-08-08
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OPTI FREE REPLENISH MULTI PURPOSE 2 OZ recall (Z-1540-2022) | Family Dollar Stores, Llc. | 2022-08-17 |