FDA Registration
Active
🇺🇸 United States
Hope&Her Vaginal Dilators
Reg #: 3029582858
·
FEI: 3029582858
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LUJENA, INC.
- Registration Number
- 3029582858
- FEI Number
- 3029582858
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11447 Rolling Hills Dr.
- City
- El Cajon
- State
- CA
- ZIP
- 92020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233689
Owner / Operator
- Firm Name
- Lujena, Inc.
- Operator Number
- 10088889
- Address
- 11447 Rolling Hills Dr.
- City
- El Cajon
- State
- CA
- Postal Code
- 92020
- Country
- US
- Correspondent
- Troy Gemmer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Vaginal | HDX | Class 2 | Obstetrics/Gynecology | No | 2024-10-30 |
Proprietary Names
Hope&Her Vaginal Dilators
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility