FDA Registration
Active
🇺🇸 United States
Mendell
Reg #: 3009998573
·
FEI: 3009998573
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Mendell
- Registration Number
- 3009998573
- FEI Number
- 3009998573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21463 Grenada Ave
- City
- Lakeville
- State
- MN
- ZIP
- 55044
- Country
- US
Regulatory Submissions
- 510(k) Number
- K942387
Owner / Operator
- Firm Name
- Mendell Machine and Manufacturing, LLC
- Operator Number
- 10042591
- Address
- 21463 Grenada Avenue
- City
- Lakeville
- State
- MN
- Postal Code
- 55044
- Country
- US
- Correspondent
- Susan Mayer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-11-10 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)