FDA Registration
Active
🇯🇵 Japan
O-RING SET FOR OF-B177 SUCTION VALVE (OF-B127)
Reg #: 9610877
·
FEI: 3008185830
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HOYA Corporation PENTAX Lifecare Division
- Registration Number
- 9610877
- FEI Number
- 3008185830
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tsutsujigaoka 1-1-110
- City
- Akishima-shi Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K131902
Owner / Operator
- Firm Name
- HOYA Corporation PENTAX Division
- Operator Number
- 8030235
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Gurvinder Nanda
US Agent
- Business Name
- HOYA CORPORATION PENTAX DIVISION
- Contact Name
- Gurvinder Nanda
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- ZIP
- 07645
- Country
- US
- [email protected]
- Phone
- 201 5712318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2014-04-22 |
Proprietary Names
O-RING SET FOR OF-B177 SUCTION VALVE (OF-B127)
HD VIDEO GASTROSCOPE (EG-2790I)
CLEANING ADAPTER, AIR/WATER (OF-G17)
CAP, CONNECTOR, FOR WATER JET FOR 30/40 (OF-B118)
FWJ CLEANING ADAPTER OE-C20 (OE-C20)
2CH CLEANING ADAPTER (OF-B162)
VIDEO GASTROSCOPE (EG-3890TK)
SUCTION CHANNEL SELECTOR FOR EC/EG 70 SE (OF-B161)
VIDEO GASTROSCOPE - (EG29-I10)
VIDEO GASTROSCOPE (EG-3490K)
SILICONE OIL (OF-Z11)
AIR/WATER/SUCTION METAL OPTIONAL (OF-B153)
VIDEO GASTROSCOPE (EG-2490K)
VIDEO GASTROSCOPE (EG-2990K)
VIDEO GASTROSCOPE (EG-2790K)
VIDEO GASTROSCOPE (EG27-i10)
VIDEO GASTROSCOPE (EG-1690K)
HD VIDEO GASTROSCOPE (EG-2990I)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility