FDA Registration
Active
🇺🇸 United States
Sodium Chloride Inhalation Solution, USP 0.9%
Reg #: 3010892830
·
FEI: 3010892830
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEPHRON SC, LLC.
- Registration Number
- 3010892830
- FEI Number
- 3010892830
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4500 12TH STREET EXT
- City
- West Columbia
- State
- SC
- ZIP
- 29172
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113033
Owner / Operator
- Firm Name
- Nephron SC, LLC.
- Operator Number
- 10052964
- Address
- 4500 12th Street Ext.
- City
- West Columbia
- State
- SC
- Postal Code
- 29172
- Country
- US
- Correspondent
- Lou Kennedy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2016-10-20 |
Proprietary Names
Sodium Chloride Inhalation Solution, USP 0.9%
Establishment Types
Manufacture Medical Device