FDA Registration
Active
🇺🇸 United States
GE XDR10
Reg #: 3004601121
·
FEI: 3004601121
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Antron Engineering & Machine Co, Inc
- Registration Number
- 3004601121
- FEI Number
- 3004601121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 170 Mechanic St
- City
- Bellingham
- State
- MA
- ZIP
- 02019
- Country
- US
Regulatory Submissions
- 510(k) Number
- K963765
Owner / Operator
- Firm Name
- Antron Engineering & Machine Co., Inc.
- Operator Number
- 10047166
- Address
- 170 Mechanic Street
- City
- Bellingham
- State
- MA
- Postal Code
- 02019
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2014-07-09 |
Proprietary Names
GE XDR10
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)