Clearance Summary
Interlude 100% Cotton Tampon received FDA 510(k) clearance under submission number K181911, sponsored by Albaad Fem. 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 2018-11-02.
- Submission: K181911
- Applicant / Sponsor: Albaad Fem
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2018-11-02
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.