FDA Registration
Active
🇯🇵 Japan
VIDEO COLONOCOPE - I10 STANDARD (EC38-I10L)
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
- K131855
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 |
|---|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2014-04-22 |
Proprietary Names
VIDEO COLONOCOPE - I10 STANDARD (EC38-I10L)
VIDEO COLONOSCOPE (EC-3890TLK)
VIDEO COLONOSCOPE (EC-3490TLI)
VIDEO COLONOSCOPE - I10 SLIM (EC34-I10L)
TUBE,IRRIGATION FOR 30/40 SERIES (OF-B113)
OE-C14 CHECK VALVE SET-10 PCS. USE WITH (OE-C15)
VIDEO COLONOSCOPE (EC-3890LI)
A/W VALVE (OF-B188)
VIDEO COLONOSCOPE (EC-3890LK)
HDVIDEO COLONOSCOPE (EC-3490LI)
WATER JET CHECK VALVE ADAPTER REPLACES O (OE-C12)
O RING SET FOR OF-B188 (OF-B192)
VIDEO COLONOSCOPE (EC-3490LK)
VALVE, SUCTION (OF-B120)
VIDEO COLONOSCOPE (EC-2990LI)
VIDEO COLONOSCOPE (EC-3890LZI)
PENTAX Distal Rubber Hood(OE-A59)
O-RING MODEL (OF-B182)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility