FDA Registration
Active
🇺🇸 United States
Needle Sleeve Bending Tool
Reg #: 1037007
·
FEI: 1037007
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GYRUS ACMI, INC.
- Registration Number
- 1037007
- FEI Number
- 1037007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2925 Appling Rd
- City
- BARTLETT
- State
- TN
- ZIP
- 38133
- Country
- US
Regulatory Submissions
- 510(k) Number
- K970809
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2011-06-28 |
Proprietary Names
Needle Sleeve Bending Tool
Establishment Types
Manufacture Medical Device