FDA Registration
Active
🇰🇷 South Korea
HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (NCN)
Reg #: 3008146331
·
FEI: 3008146331
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- M.I.Tech Co Ltd
- Registration Number
- 3008146331
- FEI Number
- 3008146331
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 174, Habuk 2gil, Jinwimyeon
- City
- Pyeongtaek Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K201160
Owner / Operator
- Firm Name
- M.I.Tech Co., Ltd.
- Operator Number
- 10030918
- Address
- 174, habuk 2gil, jinwimyeon
- City
- Pyeongtaek
- State
- Gyeonggi
- Postal Code
- 17706
- Country
- KR
- Correspondent
- Inae Kim
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 |
|---|---|---|---|---|---|
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2021-07-26 |
Proprietary Names
HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (NCN)
Establishment Types
Manufacture Medical Device