FDA Registration
Active
🇺🇸 United States
TX2 Procedure Pack
Reg #: 3009750704
·
FEI: 1000135560
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TENEX HEALTH
- Registration Number
- 3009750704
- FEI Number
- 1000135560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 26902 Vista Terrace
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153299
Owner / Operator
- Firm Name
- Tenex Health
- Operator Number
- 10042896
- Address
- 26902 Vista Terrace
- City
- Lake Forest
- State
- CA
- Postal Code
- 92630
- Country
- US
- Correspondent
- David Vancelette
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2016-09-07 |
Proprietary Names
TX2 Procedure Pack
Tenex Health TX System
TX Supply Kit
TX2 MicroTip
TX System Console
Establishment Types
Manufacture Medical Device