FDA Registration
Active
🇺🇸 United States
Next Generation Balloon Dilation System
Reg #: 3005423519
·
FEI: 3006165545
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Mentor Texas LP
- Registration Number
- 3005423519
- FEI Number
- 3006165545
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 555 Airline Drive
- City
- Coppell
- State
- TX
- ZIP
- 75019
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201115
Owner / Operator
- Firm Name
- MENTOR Texas, LP
- Operator Number
- 2125050
- Address
- 3041 Skyway Cir N, --
- City
- Irving
- State
- TX
- Postal Code
- 75038
- Country
- US
- Correspondent
- Debra Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2021-02-18 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2021-02-18 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2021-02-18 |
Proprietary Names
Next Generation Balloon Dilation System
Establishment Types
Repack or Relabel Medical Device