FDA Registration
Active
🇺🇸 United States
MR Elastography System - Accessory
Reg #: 1835830
·
FEI: 3001814065
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Creative Foam Corporation - Bremen
- Registration Number
- 1835830
- FEI Number
- 3001814065
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 405 N INDUSTRIAL DR.
- City
- BREMEN
- State
- IN
- ZIP
- 46506
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201389
Owner / Operator
- Firm Name
- Creative Foam Corporation
- Operator Number
- 9033633
- Address
- 405 N INDUSTRIAL DR., --
- City
- Bremen
- State
- IN
- Postal Code
- 46506
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2022-12-22 |
Proprietary Names
MR Elastography System - Accessory
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)