SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
FDA 510(k) clearance K120051 · decided 2012-04-20
Clearance details
- K-number
- K120051
- Device name
- SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
- Applicant
- Nephron Pharmaceuticals Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-06
- Decision date
- 2012-04-20
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, recall (Z-2053-2016) | Nephron Pharmaceuticals Corp. | 2016-06-27 |
| Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, N recall (Z-2054-2016) | Nephron Pharmaceuticals Corp. | 2016-06-27 |