FDA Registration
Active
🇯🇵 Japan
07-986-50 Head Arm Base, Up Grade Kit for Intraoperative CT
Reg #: 3011547624
·
FEI: 3011547624
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIZUHO CORPORATION
- Registration Number
- 3011547624
- FEI Number
- 3011547624
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3-30-13 HONGO
- City
- BUNKYO-KU Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K955012
Owner / Operator
- Firm Name
- MIZUHO Corporation
- Operator Number
- 9007414
- Address
- 3-30-13 HONGO
- City
- BUNKYO-KU
- State
- Tokyo
- Postal Code
- 1130033
- Country
- JP
US Agent
- Business Name
- MIZUHO AMERICA, INC.
- Contact Name
- RICHARD CHADWICK
- Address
- 30057 AHERN AVENUE
- City
- Union City
- State
- CA
- ZIP
- 94587
- Country
- US
- [email protected]
- Phone
- 510 3244500 ext. 150
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | Class 2 | Neurology | No | 2007-12-06 |
Proprietary Names
07-986-50 Head Arm Base, Up Grade Kit for Intraoperative CT
07-986-06 Radiolucent Slide Adjuster
07-985-06 Head Holder, (Radiolucent)
07-985-07 Head Pin, (Radiolucent)
07-986-04 Radiolucent Rotatable Head Holder
07-986-05 Radiolucent Basal Frame
07-986-03 Radiolucent Head Frame Up Grade Kit
07-986-60 Radiolucent Head Frame Basic Set
07-952-08 Head Arm Base, Pin dia. 16mm
07-952-07 Head Arm Base, Pin dia. 19mm
07-952-01 HEAD ARM BASE
07-986-07 Head Pin, (Radiolucent, Carbon 2)
07-952-08A Head Arm Base, Pin dia. 16 mm, Outside
Establishment Types
Export Device to the United States But Perform No Other Operation on Device