Clearance Summary
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ received FDA 510(k) clearance under submission number K930149, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-03-02.
- Submission: K930149
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 1994-03-02
Classification & Regulation
This clearance is catalogued under FDA product code HEB and 21 CFR 884.5470, within the Obstetrics/Gynecology review panel as a Class II device.