FDA Registration
Active
🇺🇸 United States
LOBO Handpiece (LOBO-HP)
Reg #: 3016444913
·
FEI: 3016444913
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Okami Medical Inc.
- Registration Number
- 3016444913
- FEI Number
- 3016444913
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Argonaut, Suite 100
- City
- Aliso Viejo
- State
- CA
- ZIP
- 92656
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192083
Owner / Operator
- Firm Name
- Okami Medical Inc.
- Operator Number
- 10061852
- Address
- 8 Argonaut, Suite 100, Suite 100
- City
- Aliso Viejo
- State
- CA
- Postal Code
- 92656
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2019-11-25 |
Proprietary Names
LOBO Handpiece (LOBO-HP)
LOBO Vascular Occluder (LOBO-3)
Establishment Types
Manufacture Medical Device