FDA Registration
Active
🇰🇷 South Korea
LS-627A Balboa Comfort LSO Brace sizes XS XL
Reg #: 3011287176
·
FEI: 3011287176
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ONSURGICAL CORP.
- Registration Number
- 3011287176
- FEI Number
- 3011287176
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- F1013 Misa Centum Biz, 45, Jojeong-daero, Hanam-si, Gyeonggi-do
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Onsurgical Corp.
- Operator Number
- 10048066
- Address
- 207, Hyundai Shopping Complex 434-2, Junggye-dong, Nowon-ku
- City
- Seoul
- State
- KR-11
- Postal Code
- 139-859
- Country
- KR
- Correspondent
- Nic Lim
US Agent
- Business Name
- ST&G USA Corporation
- Contact Name
- Glenn Choi
- Address
- 2691 Saturn St
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 714 5240663
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2014-12-03 |
Proprietary Names
LS-627A Balboa Comfort LSO Brace sizes XS XL
LS-637B Avalon Contour LSO Brace sizes 2X 4X
LS-631A Capri Comfort LSO Brace - sizes XS - XL
LS-631B Capri Comfort LSO Brace - sizes 2X - 4X
LS-637A Avalon Contour LSO Brace sizes XS XL
LS-627B Balboa Comfort LSO Brace sizes 2X 4X
Establishment Types
Manufacture Medical Device