FDA Registration
Active
🇬🇧 United Kingdom
PICO 7Y Single Use Negative Pressure Wound Therapy System
Reg #: 8043484
·
FEI: 3002808194
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Smith & Nephew Medical Ltd
- Registration Number
- 8043484
- FEI Number
- 3002808194
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 Hessle Road
- City
- HULL East Riding of Yorkshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K203716
Owner / Operator
- Firm Name
- SMITH AND NEPHEW MEDICAL LTD.
- Operator Number
- 9001952
- Address
- 101 HESSLE RD., --
- City
- HULL
- State
- GB-NOTA
- Postal Code
- HU3 2BN
- Country
- GB
- Correspondent
- Samantha Neilson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | QFC | Class 2 | General, Plastic Surgery | No | 2022-04-06 |
Proprietary Names
PICO 7Y Single Use Negative Pressure Wound Therapy System
PICO 14 Single Use Negative Pressure Wound Therapy System
PICO 7 Single Use Negative Pressure Wound Therapy System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device