K252939
- 510(k) number
- K252939
- Device name
- COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
- Applicant
- Cotton High Tech S.L. ES
- Product code
- HEB — Tampon, Menstrual, Unscented
- Decision date
- 2025-10-09
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K252939.pdf
Official FDA record: K252939
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.