FDA Registration
Active
🇰🇷 South Korea
PLAXPOT
Reg #: 3013924508
·
FEI: 3013924508
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GCS CO.,LTD
- Registration Number
- 3013924508
- FEI Number
- 3013924508
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #301~327, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K220493
Owner / Operator
- Firm Name
- GCS Co.,LTD
- Operator Number
- 10057779
- Address
- #301~327, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13211
- Country
- KR
US Agent
- Business Name
- Compliance Insight, Inc.
- Contact Name
- Cynthia Ipach
- Address
- 497 Circle Freeway Drive, Suite 230
- City
- Cincinnati
- State
- OH
- ZIP
- 45246
- Country
- US
- [email protected]
- Phone
- 513 8603512 ext. 306
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Low Power Electrosurgical Devices For Skin Lesion Destruction | QVJ | Class 2 | General, Plastic Surgery | No | 2024-10-30 |
Proprietary Names
PLAXPOT
Plaxpot Multi Plasma
Establishment Types
Manufacture Medical Device