FDA Registration
Active
🇺🇸 United States
Lipi-Flow
Reg #: 3002939152
·
FEI: 3002939152
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Trelleborg Sealing Solutions River Falls
- Registration Number
- 3002939152
- FEI Number
- 3002939152
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 434 Highland Dr
- City
- River Falls
- State
- WI
- ZIP
- 54022
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161357
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
- Correspondent
- Heaven - Clausen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Eyelid Thermal Pulsation System | ORZ | Class 2 | Ophthalmic | No | 2018-06-26 |
Proprietary Names
Lipi-Flow
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)