FDA Registration
Active
🇰🇷 South Korea
OLIZ (model: LTB-1000A)
Reg #: 3021743553
·
FEI: 3021743553
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LTBIO CO., LTD.
- Registration Number
- 3021743553
- FEI Number
- 3021743553
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1501, tech-dong, 124, Sagimakgol-ro, Jungwon-gu Seongnam-si, GYEONGGI, 13207, KOREA, SOUTH
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K221189
Owner / Operator
- Firm Name
- LTBIO Co., Ltd.
- Operator Number
- 10084318
- Address
- 1501, tech-dong, 124, Sagimakgol-ro, Jungwon-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13207
- Country
- KR
- Correspondent
- JAE-YOUNG KIM
US Agent
- Business Name
- KMC USA, Inc
- Contact Name
- SEOK WOO KIM
- Address
- 5450 ASTOR LANE #203
- City
- Rolling Mdws
- State
- IL
- ZIP
- 60008
- Country
- US
- [email protected]
- Phone
- 847 9241545
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2022-09-14 |
Proprietary Names
OLIZ (model: LTB-1000A)
Establishment Types
Manufacture Medical Device