Clearance Summary
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON received FDA 510(k) clearance under submission number K092054, sponsored by Tosama D.D.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2009-07-29.
- Submission: K092054
- Applicant / Sponsor: Tosama D.D.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2009-07-29
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.