K253719
- 510(k) number
- K253719
- Device name
- Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
- Applicant
- Unibeauty (Hubei) Technology Co., Ltd. CN
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2025-12-17
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253719.pdf
Official FDA record: K253719
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.