FDA Registration
Active
🇰🇷 South Korea
CanalPro CL2
Reg #: 3010551934
·
FEI: 3010551934
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SAEYANG CO., LTD.
- Registration Number
- 3010551934
- FEI Number
- 3010551934
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- (Galsan-Dong), 348 SEONGSEO-RO
- City
- DALSEO-GU Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K123582
Owner / Operator
- Firm Name
- SAEYANG CO., LTD.
- Operator Number
- 10086948
- Address
- (Galsan-Dong), 348 SEONGSEO-RO
- City
- DALSEO-GU
- State
- Daegu
- Postal Code
- 42697
- Country
- KR
- Correspondent
- JUNG PIL SHIN
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 |
|---|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2022-12-26 |
Proprietary Names
CanalPro CL2
Endo A Class
Establishment Types
Manufacture Medical Device