FDA Registration
Active
🇺🇸 United States
Seed Implant Needle Set
Reg #: 1037598
·
FEI: 1037598
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THERAGENICS CORP.
- Registration Number
- 1037598
- FEI Number
- 1037598
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5203 BRISTOL INDUSTRIAL WAY
- City
- BUFORD
- State
- GA
- ZIP
- 30518
- Country
- US
Regulatory Submissions
- 510(k) Number
- K974118
Owner / Operator
- Firm Name
- Theragenics Corporation
- Operator Number
- 1037598
- Address
- 5203 BRISTOL INDUSTRIAL WAY, --
- City
- Buford
- State
- GA
- Postal Code
- 30518
- Country
- US
- Correspondent
- Kenneth Gaitor
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2016-03-03 |
Proprietary Names
Seed Implant Needle Set
Establishment Types
Manufacture Medical Device