FDA Registration
Active
🇰🇷 South Korea
HILZO Esophageal Stents
Reg #: 3014172183
·
FEI: 3014172183
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BCM CO., LTD.
- Registration Number
- 3014172183
- FEI Number
- 3014172183
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 178, Deoksan-ro, Ilsanseo-gu
- City
- Goyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K223266
Owner / Operator
- Firm Name
- BCM Co., Ltd.
- Operator Number
- 10079431
- Address
- 178, Deoksan-ro, Ilsanseo-gu
- City
- Goyang-si
- State
- Gyeonggi
- Postal Code
- 10208
- Country
- KR
- Correspondent
- Hyunchul Sim
US Agent
- Business Name
- ProMedoss
- Contact Name
- BOSMAT FRIEDMAN
- Address
- 6026 Beech Cove Ln.
- City
- Charlotte
- State
- NC
- ZIP
- 28269
- Country
- US
- [email protected]
- Phone
- 980 3081636
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2024-03-01 |
Proprietary Names
HILZO Esophageal Stents
Hilzo esophageal stents
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)