FDA Registration
Active
🇺🇸 United States
VersaJet II Hydrosurgery System
Reg #: 3010034780
·
FEI: 3010034780
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Smith & Nephew, Inc.
- Registration Number
- 3010034780
- FEI Number
- 3010034780
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2225 Cedars Rd Ste A
- City
- Lawrenceville
- State
- GA
- ZIP
- 30043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110958
Owner / Operator
- Firm Name
- SMITH & NEPHEW, INC.
- Operator Number
- 9002406
- Address
- 150 Minuteman Road
- City
- Andover
- State
- MA
- Postal Code
- 01810
- Country
- US
- Correspondent
- Beth - Zis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2011-08-02 |
Proprietary Names
VersaJet II Hydrosurgery System
Establishment Types
Repack or Relabel Medical Device