K232060
- 510(k) number
- K232060
- Device name
- TOSAMA Reusable Applicator
- Applicant
- Tosama, D.O.O. SI
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2024-04-12
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232060.pdf
Official FDA record: K232060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.