K252613
- 510(k) number
- K252613
- Device name
- Unscented menstrual three-piece applicator tampon
- Applicant
- Unibeauty (Hubei) Technology Co., Ltd. CN
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2025-09-19
- Date received
- 2025-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252613.pdf
Official FDA record: K252613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.