FDA Registration
Inactive
🇰🇷 South Korea
Duralon Occlusion Balloon, 3 Lumen
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENT CO., LTD. PLANT DIVISION
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 1119~1122, 1124~1126, 63 Samwon-ro, Deogyang-gu
- City
- Goyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K013737
Owner / Operator
- Firm Name
- SHENT Co., Ltd. Plant Division
- Operator Number
- 10093604
- Address
- Room 1119~1122, 1124~1126, 63 Samwon-ro, Deogyang-gu
- City
- Goyang-si
- State
- Gyeonggi
- Postal Code
- 10550
- Country
- KR
- Correspondent
- Seung Il Suh
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman Ave Ste 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2025-06-11 |
Proprietary Names
Duralon Occlusion Balloon, 3 Lumen
Establishment Types
Manufacture Medical Device