FDA Registration
Active
🇺🇸 United States
Hyper-C
Reg #: 3010663372
·
FEI: 3010663372
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DEGEN MEDICAL
- Registration Number
- 3010663372
- FEI Number
- 3010663372
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1321C N Cashua Dr
- City
- Florence
- State
- SC
- ZIP
- 29501
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150759
Owner / Operator
- Firm Name
- DeGen Medical
- Operator Number
- 10048016
- Address
- 1321-C North Cashua Drive
- City
- Florence
- State
- SC
- Postal Code
- 29501
- Country
- US
- Correspondent
- Craig Black
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-12-16 |
Proprietary Names
Hyper-C
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility