FDA Registration
Active
🇰🇷 South Korea
Electrode LIFT (Model: 2X80)
Reg #: 3010952064
·
FEI: 3010952064
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CHUNGWOO CO., LTD.
- Registration Number
- 3010952064
- FEI Number
- 3010952064
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- (Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro
- City
- Geumcheon-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222709
Owner / Operator
- Firm Name
- CHUNGWOO CO., LTD.
- Operator Number
- 10087784
- Address
- (Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro
- City
- Geumcheon-gu
- State
- Seoul
- Postal Code
- 08591
- Country
- KR
- Correspondent
- IL KWON LEE
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-04-10 |
Proprietary Names
Electrode LIFT (Model: 2X80)
Neutral Cable (Model: CWM-910T-H22-1)
APOLEX Tite (Model: CWM-910T)
Foot Switch (Model: CWM-910T-H21)
Retraction (Model: CWM-910T)
Hand Piece LIFT (Model: HP20-80)
Hand Piece SMART (Model: HP20-180)
Electrode SMART (Model: 2X180)
Hand Piece Electrode LIPO (Model: AE40-300)
Power cable (Models: SP-30H, IS-14)
Hand Piece LIPO (Model: HP40-300)
Hand Piece Electrode SMART (Model: AE20-180)
Neutral Pad (Model: 9541C)
Electrode LIPO (Model: 4X300)
Hand Piece Electrode LIFT (Model: AE20-80)
Establishment Types
Manufacture Medical Device