Clearance Summary
KOTEX (R) GOODNITES received FDA 510(k) clearance under submission number K864187, 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 1986-12-11.
- Submission: K864187
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5425
- Decision date: 1986-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HHL and 21 CFR 884.5425, within the Obstetrics/Gynecology review panel as a Class II device.