FDA Registration
Active
🇯🇵 Japan
Single Use 3-Lumen Sphincterotome V
Reg #: 3010188783
·
FEI: 3010188783
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- JAPAN GAS COMPANY LIMITED
- Registration Number
- 3010188783
- FEI Number
- 3010188783
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2-7, DAIKOKUCHO, TSURUMI-KU
- City
- YOKOHAMA Kanagawa
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K950166
Owner / Operator
- Firm Name
- JAPAN GAS COMPANY LIMITED
- Operator Number
- 10042580
- Address
- 2-7, DAIKOKUCHO, TSURUMI-KU
- City
- YOKOHAMA
- State
- Kanagawa
- Postal Code
- 230-0053
- Country
- JP
- Correspondent
- Hisayoshi Nakamoto
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 | 2015-12-18 |
Proprietary Names
Single Use 3-Lumen Sphincterotome V
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)