K241748
- 510(k) number
- K241748
- Device name
- Intimate Rose Vaginal Dilators
- Applicant
- Plus EV Holdings Dba Intimate Rose MO · US
- Product code
- HDX — Dilator, Vaginal
- Decision date
- 2024-08-14
- Date received
- 2024-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241748.pdf
Official FDA record: K241748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.