Hope&Her Vaginal Dilators — Lujena, Inc. (510(k) K233689)
Hope&Her Vaginal Dilators — Lujena, Inc. (510(k) K233689) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Hope&Her Vaginal Dilators; Applicant: Lujena, Inc.; Clearance track: 510(k).
| Device name | Hope&Her Vaginal Dilators |
|---|---|
| Applicant | Lujena, Inc. |
| Clearance track | 510(k) |
| Submission number | K233689 |
| Decision | Substantially Equivalent |
| Decision date | 2024-05-02 |
| Date received | 2023-11-17 |
| Product code | HDX |
| Device class | 2 |
| Medical specialty | Obstetrics/Gynecology |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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