FDA Registration
Active
🇯🇵 Japan
FMD Peripheral Guide Wire F-18 Flex 400
Reg #: 3013023134
·
FEI: 3013023134
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FMD. Co., Ltd.
- Registration Number
- 3013023134
- FEI Number
- 3013023134
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-166 Shimoobari Nakashima
- City
- Komaki Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K240460
Owner / Operator
- Firm Name
- FMD Co., Ltd.
- Operator Number
- 10052039
- Address
- Sasazuka Daiichi Bldg. 8F, 1-57-7 Sasazuka, Shibuya-ku
- City
- Tokyo
- State
- JP-13
- Postal Code
- 151-0073
- Country
- JP
- Correspondent
- Mayumi Ito
US Agent
- Business Name
- Far West Consulting, LLC
- Contact Name
- Max Bynum
- Address
- 4768 Woodview Dr
- City
- Santa Rosa
- State
- CA
- ZIP
- 95405
- Country
- US
- [email protected]
- Phone
- 707 2900082
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2024-07-10 |
Proprietary Names
FMD Peripheral Guide Wire F-18 Flex 400
Establishment Types
Manufacture Medical Device