FDA Registration
Active
🇬🇧 United Kingdom
hekaDrill
Reg #: 3016172274
·
FEI: 3016172274
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ZETHON LTD
- Registration Number
- 3016172274
- FEI Number
- 3016172274
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Halton Brook Business Park, Weston Road
- City
- ASTON CLINTON Buckinghamshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K193630
Owner / Operator
- Firm Name
- Zethon Ltd
- Operator Number
- 10058256
- Address
- 2 Halton Brook Business Park, Weston Road
- City
- ASTON CLINTON
- State
- Buckinghamshire
- Postal Code
- HP22 5WF
- Country
- GB
- Correspondent
- Will Desoutter
US Agent
- Business Name
- De Soutter Medical USA Inc
- Contact Name
- Collin Metz
- Address
- 224 Rolling Hill Rd Ste 12a
- City
- Mooresville
- State
- NC
- ZIP
- 28117
- Country
- US
- [email protected]
- Phone
- 704 6559040
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2021-12-13 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2021-12-13 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2021-12-13 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2021-12-13 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2021-12-13 |
Proprietary Names
hekaDrill
Establishment Types
Manufacture Medical Device