FDA Registration
Active
🇺🇸 United States
Tympanostomy Tube Delivery System
Reg #: 3012130335
·
FEI: 3012130335
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tusker Medical Inc.
- Registration Number
- 3012130335
- FEI Number
- 3012130335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7000 W. William Cannon Dr., Suite 110
- City
- Austin
- State
- TX
- ZIP
- 78735
- Country
- US
Regulatory Submissions
- PMA Number
- P190016
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tympanostomy Tube Delivery Product With Drug | QJA | Class 3 | Unknown | No | 2020-03-12 |
Proprietary Names
Tympanostomy Tube Delivery System
Establishment Types
Manufacture Medical Device