K242105
- 510(k) number
- K242105
- Device name
- SABA Tampons
- Applicant
- Essity Higiene Y Salud Mexico. S.A. DE C.V. MX
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2025-04-01
- Date received
- 2024-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242105.pdf
Official FDA record: K242105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.