FDA Registration
Active
🇰🇷 South Korea
Isolation Gown, Antimicrobial, Disposable
Reg #: 3021742060
·
FEI: 3021742060
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FUTUREGEN LIFE CO LTD
- Registration Number
- 3021742060
- FEI Number
- 3021742060
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 202, Dongbu-root BLDG, 36, Hwangsaeul-ro 200beon-gil, Bundang-su, Seongnam-si
- City
- Bundang-su, Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K223304
Owner / Operator
- Firm Name
- Futuregen Life Co Ltd
- Operator Number
- 10084316
- Address
- 202, Dongbu-root BLDG, 36, Hwangsaeul-ro 200beon-gil, Bundang-su, Seongnam-si
- City
- Bundang-su, Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13595
- Country
- KR
- Correspondent
- Heung J Kim
US Agent
- Business Name
- YTS Global Inc
- Contact Name
- Won Lee
- Address
- 7406 Alban Station Ct., A108
- City
- Springfield
- State
- VA
- ZIP
- 22150
- Country
- US
- [email protected]
- Phone
- 703 3408178
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2025-01-01 |
Proprietary Names
Isolation Gown, Antimicrobial, Disposable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)