FDA Registration
Active
🇺🇸 United States
POLO CUSTOM PRODUCTS
Reg #: 1927395
·
FEI: 1927395
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- POLO CUSTOM PRODUCTS
- Registration Number
- 1927395
- FEI Number
- 1927395
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 902 NORTH BIRCH RD.
- City
- MONTICELLO
- State
- IA
- ZIP
- 52310
- Country
- US
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 |
| Wearable Automated External Defibrillator | MVK | Class 3 | Unknown | No | 2021-08-18 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2025-02-05 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2025-01-10 |
Proprietary Names
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)