FDA Registration
Active
🇯🇵 Japan
KONO SEISAKUSHO
Reg #: 3013849323
·
FEI: 3013849323
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- KONO SEISAKUSHO
- Registration Number
- 3013849323
- FEI Number
- 3013849323
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-09-25 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-02-20 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2020-10-06 |
Proprietary Names
PICOCLAMP
CROWNJUN Micro Sheet K
CROWNJUN Super Micro Sheet K
CROWNJUN Micro Scale
Single Retractor
Double Retractor
CROWNJUN Nylon Suture
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198