FDA Registration
Active
🇯🇵 Japan
KD-650L
Reg #: 9614641
·
FEI: 3003995201
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AOMORI OLYMPUS CO., LTD.
- Registration Number
- 9614641
- FEI Number
- 3003995201
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2-248-1 OKKONOKI
- City
- KUROISHI-SHI Aomori
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K092309
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2010-02-23 |
Proprietary Names
KD-650L
KD-620UR
KD-630L
KD-612L
KD-640L
KD-650U
KD-610L
KD-612U
KD-620LR
KD-611L
Establishment Types
Manufacture Medical Device