FDA Registration
Active
🇺🇸 United States
EP Granules BVF
Reg #: 3021988499
·
FEI: 3021988499
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELUTE, INC.
- Registration Number
- 3021988499
- FEI Number
- 3021988499
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 417 S WAKARA WAY, #3510
- City
- Salt Lake City
- State
- UT
- ZIP
- 84108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180853
Owner / Operator
- Firm Name
- Elute, Inc.
- Operator Number
- 10085208
- Address
- 417 S WAKARA WAY, #3510
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84108
- Country
- US
- Correspondent
- Ashok Khandkar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2022-05-19 |
Proprietary Names
EP Granules BVF
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility