FDA Registration
Active
🇺🇸 United States
Xenograft Bovine Bone Particulate
Reg #: 3014003617
·
FEI: 3014003617
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen
- Registration Number
- 3014003617
- FEI Number
- 3014003617
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6455 City West Pkwy #100
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240133
Owner / Operator
- Firm Name
- Collagen Solutions/TissX LLC d/b/a Evergen
- Operator Number
- 10088410
- Address
- 6455 City West Pkwy
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- Sheila Hunter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2024-12-12 |
Proprietary Names
Xenograft Bovine Bone Particulate
Establishment Types
Manufacture Medical Device