FDA Registration
Active
🇰🇷 South Korea
JLK-SDH
Reg #: 3038177848
·
FEI: 3038177848
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- JLK, INC.
- Registration Number
- 3038177848
- FEI Number
- 3038177848
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Teheranro33-Gil 5/11f
- City
- Gangnam Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K243611
Owner / Operator
- Firm Name
- JLK Inc
- Operator Number
- 10092928
- Address
- 11F, 5, Teheran-ro 33-gil
- City
- Gangnam-gu
- State
- Seoul
- Postal Code
- 06141
- Country
- KR
US Agent
- Business Name
- JLK USA
- Contact Name
- Do Hyun Kim
- Address
- 5201 Great America Pkwy Ste 407
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
- [email protected]
- Phone
- 530 6013259
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | Class 2 | Radiology | No | 2025-03-12 |
Proprietary Names
JLK-SDH
Establishment Types
Manufacture Medical Device