FDA Registration
Active
🇬🇧 United Kingdom
Paxman Scalp Cooler
Reg #: 3008938259
·
FEI: 3008938259
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PAXMAN COOLERS LIMITED
- Registration Number
- 3008938259
- FEI Number
- 3008938259
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- International House, Penistone Road
- City
- Fenay Bridge, Huddersfield Kirklees
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K163484
Owner / Operator
- Firm Name
- Head of Operations and Quality
- Operator Number
- 10054996
- Address
- International House, Penistone Road
- City
- Fenay Bridge, Huddersfield
- State
- East Riding of Yorkshire
- Postal Code
- HD8 0LE
- Country
- GB
- Correspondent
- Alex Sheldrake
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scalp Cooling System | PMC | Class 2 | General, Plastic Surgery | No | 2017-05-23 |
Proprietary Names
Paxman Scalp Cooler
Establishment Types
Manufacture Medical Device