FDA Registration
Active
🇯🇵 Japan
P200-CU-230
Reg #: 3025764223
·
FEI: 3025764223
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- FORCE ENGINEERING CO.LTD
- Registration Number
- 3025764223
- FEI Number
- 3025764223
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2559-2 Ishii
- City
- Utsunomiya Tochigi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K132264
Owner / Operator
- Firm Name
- FORCE ENGINEERING CO.LTD
- Operator Number
- 10086963
- Address
- 2559-2 Ishii
- City
- Utsunomiya
- State
- Tochigi
- Postal Code
- 321-0912
- Country
- JP
- Correspondent
- Satoru Ikeda
US Agent
- Business Name
- NSK America Corporation
- Contact Name
- Sean Kaufman
- Address
- Office, 1800 Global Parkway Hoffman Estates
- City
- Hoffman Est
- State
- IL
- ZIP
- 60192
- Country
- US
- [email protected]
- Phone
- 888 6751675
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2022-12-27 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2022-12-27 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2022-12-27 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2022-12-27 |
Proprietary Names
P200-CU-230
P200-CU-120
Primado2
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)