FDA Registration
Active
🇺🇸 United States
Trelleborg Sealing Solutions Litchfield
Reg #: 3004126422
·
FEI: 3004126422
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Trelleborg Sealing Solutions Litchfield
- Registration Number
- 3004126422
- FEI Number
- 3004126422
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 45 N Precision Dr
- City
- Litchfield
- State
- MN
- ZIP
- 55355
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161166
Owner / Operator
- Firm Name
- Trelleborg Sealing Solutions Plymouth LLC
- Operator Number
- 9102441
- Address
- 1100 XENIUM LANE NORTH, --
- City
- Minneapolis
- State
- MN
- Postal Code
- 55441
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2020-01-14 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2020-01-14 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-01-14 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)