FDA Registration
Active
🇺🇸 United States
UreTron Multi Probe Lithotripter System
Reg #: 3009543101
·
FEI: 3009543101
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ultratellege USA Co. LTD.
- Registration Number
- 3009543101
- FEI Number
- 3009543101
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2111 Peninsula Drive
- City
- Erie
- State
- PA
- ZIP
- 16506
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160198
Owner / Operator
- Firm Name
- Ultratellege USA Co. Ltd
- Operator Number
- 10040377
- Address
- 2111 Peninsula Drive
- City
- Erie
- State
- PA
- Postal Code
- 16506
- Country
- US
- Correspondent
- Tao Song
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2016-08-01 |
Proprietary Names
UreTron Multi Probe Lithotripter System
Establishment Types
Manufacture Medical Device