FDA Registration
Inactive
🇰🇷 South Korea
HUTOM INC.
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- HUTOM INC.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F, 279, Dongmak-ro, Mapo-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K233457
Owner / Operator
- Firm Name
- Hutom Inc.
- Operator Number
- 10095810
- Address
- 6F, 279, Dongmak-ro, Mapo-gu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 04155
- Country
- KR
- Correspondent
- Woo Jin Hyung
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-05-04 |
Proprietary Names
RUS
Establishment Types
Manufacture Medical Device