FDA Registration
Active
🇺🇸 United States
CivaSheet Pd-103
Reg #: 3008807866
·
FEI: 3008807866
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CivaTech Oncology Inc.
- Registration Number
- 3008807866
- FEI Number
- 3008807866
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 627 Davis Dr., Tech 7, Suite 200
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140490
Owner / Operator
- Firm Name
- Civatech Oncology Inc.
- Operator Number
- 10043507
- Address
- 627 Davis Dr., Suite 200
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Suzanne T Babcock
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Source, Brachytherapy, Radionuclide | KXK | Class 2 | Radiology | No | 2014-11-05 |
Proprietary Names
CivaSheet Pd-103
Establishment Types
Manufacture Medical Device