K240708
- 510(k) number
- K240708
- Device name
- Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
- Applicant
- Suzhou Borage Medical Technology Co., Ltd. CN
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2024-05-10
- Date received
- 2024-03-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240708.pdf
Official FDA record: K240708
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.