FDA Registration
Active
🇯🇵 Japan
Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1
Reg #: 3008876063
·
FEI: 3008876063
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KITAZATO CORPORATION
- Registration Number
- 3008876063
- FEI Number
- 3008876063
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100-10 Yanagishima
- City
- Fuji Shizuoka
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K131491
Owner / Operator
- Firm Name
- Kitazato Corporation
- Operator Number
- 10045321
- Address
- 100-10 Yanagishima
- City
- Fuji
- State
- Shizuoka
- Postal Code
- 416-0932
- Country
- JP
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2013-11-05 |
Proprietary Names
Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1
Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device