FDA Registration
Active
🇯🇵 Japan
PICOCLAMP
Reg #: 3013849323
·
FEI: 3013849323
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KONO SEISAKUSHO
- Registration Number
- 3013849323
- FEI Number
- 3013849323
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Soya 2-11-10
- City
- Ichikawa Chiba
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K230281
Owner / Operator
- Firm Name
- Kono Seisakusho
- Operator Number
- 10077957
- Address
- Soya 2-11-10
- City
- Ichikawa
- State
- Chiba
- Postal Code
- 272-0832
- Country
- JP
- Correspondent
- Hiroyuki Arai
US Agent
- Business Name
- Mitaka USA
- Contact Name
- Max Sturgis
- Address
- 842 Oakridge Rd N
- City
- Park City
- State
- UT
- ZIP
- 84098
- Country
- US
- [email protected]
- Phone
- 720 7729110
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-11-10 |
Proprietary Names
PICOCLAMP
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198