FDA Registration
Active
🇯🇵 Japan
07-157-11 TAPERED SELF-RETAINING RETRACTOR 5mm 37cm (HADEISHI version)
Reg #: 9680242
·
FEI: 3009504761
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIZUHO Corporation Gosen Factory
- Registration Number
- 9680242
- FEI Number
- 3009504761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3631-14, Akomi
- City
- Gosen Niigata
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K902517
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 |
|---|---|---|---|---|---|
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2016-09-07 |
Proprietary Names
07-157-11 TAPERED SELF-RETAINING RETRACTOR 5mm 37cm (HADEISHI version)
07-157-01 TAPERED SELF-RETAINING RETRACTOR 42cm
07-173-02 SELF-RETAINING RETRACTOR TITANIUM 37cm
07-174-23 SELF-RETAINING RETRACTOR STAINLESS STEEL 24cm
07-157-02 TAPERED SELF-RETAINING RETRACTOR 37cm
07-157-12 TAPERED SELF-RETAINING RETRACTOR 6mm 37cm (HADEISHI version)
07-158-01 TAPERED SELF-RETAINING RETRACTOR 42cm W
07-158-02 TAPERED SELF-RETAINING RETRACTOR 37cm W
07-174-32 SELF-RETAINING RETRACTOR Clamp Double
07-174-26 SELF-RETAINING RETRACTOR STAINLESS STEEL 48cm
07-174-02 SELF-RETAINING RETRACTOR TITANIUM 37cm W
07-175-00 SELF-RETAINING RETRACTOR ATTACHMENT F-1
07-173-00 SELF-RETAINING RETRACTOR SINGLE
07-173-01 SELF-RETAINING RETRACTOR TITANIUM 42cm
07-174-21 SELF-RETAINING RETRACTOR STAINLESS STEEL 37cm
07-174-00 SELF-RETAINING RETRACTOR DOUBLE
07-174-28 SELF-RETAINING RETRACTOR TITANIUM 42cm Without Clamp
07-174-31 SELF-RETAINING RETRACTOR Clamp Single
07-174-29 SELF-RETAINING RETRACTOR TITANIUM 37cm Without Clamp
07-955-00 UNIVERSAL ATTACHMENT
07-174-22 SELF-RETAINING RETRACTOR STAINLESS STEEL 42cm
07-174-24 TAPERED SELF-RETAINING RETRACTOR 42cm Without Clamp
07-174-01 SELF-RETAINING RETRACTOR TITANIUM 42cm W
07-174-25 TAPERED SELF-RETAINING RETRACTOR 37cm Without Clamp
Establishment Types
Manufacture Medical Device