FDA Registration
Active
🇰🇷 South Korea
SurFuse(tm) II Putty
Reg #: 3003828812
·
FEI: 3003828812
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HANS BIOMED CORP.
- Registration Number
- 3003828812
- FEI Number
- 3003828812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 64, YUSEONG-DAERO 1628 BEON-GIL, Yuseong-gu
- City
- Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K130235
Owner / Operator
- Firm Name
- HANS BIOMED CORP.
- Operator Number
- 9054234
- Address
- 64, Yuseong-daero 1628 beon-gil, Yuseong-gu
- City
- Daejeon
- State
- KR-NOTA
- Postal Code
- 34054
- Country
- KR
US Agent
- Business Name
- Suhyeon Park
- Contact Name
- Suhyeon Park
- Address
- 140 Sylvan Ave Ste 301
- City
- Englewd Clfs
- State
- NJ
- ZIP
- 07632
- Country
- US
- [email protected]
- Phone
- 201 2242333 ext. 2333
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2014-02-20 |
Proprietary Names
SurFuse(tm) II Putty
ExFuse(tm) II Putty
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device