K241064
- 510(k) number
- K241064
- Device name
- Unscented Tampon
- Applicant
- Shandong Intco Hygiene Products Co., Ltd. CN
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2025-01-10
- Date received
- 2024-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241064.pdf
Official FDA record: K241064
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.