Clearance Summary
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS received FDA 510(k) clearance under submission number K080775, sponsored by Tosama D.D.. 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 2008-09-10.
- Submission: K080775
- Applicant / Sponsor: Tosama D.D.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2008-09-10
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.