FDA Registration
Active
🇯🇵 Japan
H. OGINO & CO., LTD.
Reg #: 5470
·
FEI: 5470
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- H. OGINO & CO., LTD.
- Registration Number
- 5470
- FEI Number
- 5470
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Yamashitacho 75, Nakaku
- City
- Yokohama Kanagawa
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K930446
Owner / Operator
- Firm Name
- H. Ogino & Co., Ltd.
- Operator Number
- 10051654
- Address
- Yamashitacho 75, Nakaku
- City
- Yokohama
- State
- Kanagawa
- Postal Code
- 2310023
- Country
- JP
- Correspondent
- Shota Nakagawa
US Agent
- Business Name
- Marco Ophthalmic, Inc.
- Contact Name
- Cheryl Bennett
- Address
- 11825 Central Parkway
- City
- JAX
- State
- FL
- ZIP
- 32224
- Country
- US
- [email protected]
- Phone
- 904 6429330
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2016-04-17 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2016-04-17 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2016-04-17 |
| Exophthalmometer | HLS | Class 1 | Ophthalmic | No | 2016-04-17 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2016-04-17 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2016-04-17 |
Proprietary Names
Set, lens, trial, ophthalmic
Refractor, manual, non-powered, including phoropter
Frame, trial, ophthalmic
Exophthalmometer
Chart, visual acuity
Instrument, measuring, lens, ac-powered
Establishment Types
Export Device to the United States But Perform No Other Operation on Device