FDA Registration
Active
🇺🇸 United States
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
Reg #: 1927395
·
FEI: 1927395
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLO CUSTOM PRODUCTS
- Registration Number
- 1927395
- FEI Number
- 1927395
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 902 NORTH BIRCH RD.
- City
- MONTICELLO
- State
- IA
- ZIP
- 52310
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221661
Owner / Operator
- Firm Name
- Polo Custom Products
- Operator Number
- 9919026
- Address
- 3601 SW 29th Street, --
- City
- Topeka
- State
- KS
- Postal Code
- 66614
- Country
- US
- Correspondent
- Dawn R Silver
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-12-04 |
Proprietary Names
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)