FDA Registration
Active
🇺🇸 United States
Polypectomy Snares
Reg #: 1222168
·
FEI: 1222168
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TeleMed Systems
- Registration Number
- 1222168
- FEI Number
- 1222168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 KANE INDUSTRIAL DR.
- City
- HUDSON
- State
- MA
- ZIP
- 01749
- Country
- US
Regulatory Submissions
- 510(k) Number
- K901428
Owner / Operator
- Firm Name
- SHENT USA, INC.
- Operator Number
- 10078923
- Address
- 8 Kane Industrial Drive
- City
- Hudson
- State
- MA
- Postal Code
- 01749
- Country
- US
- Correspondent
- Hanbin Suh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2020-11-10 |
Proprietary Names
Polypectomy Snares
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device