K250629
- 510(k) number
- K250629
- Device name
- Sutil Rich Personal Lubricant
- Applicant
- Hathor Professional Skincare , Ltd. CA
- Product code
- NUC — Lubricant, Personal
- Decision date
- 2025-05-02
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250629.pdf
Official FDA record: K250629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.