Clearance Summary
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS received FDA 510(k) clearance under submission number K032080, sponsored by Rostam , Ltd.. 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 2003-08-14.
- Submission: K032080
- Applicant / Sponsor: Rostam , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 2003-08-14
Classification & Regulation
This clearance is catalogued under FDA product code HIL and 21 CFR 884.5460, within the Obstetrics/Gynecology review panel as a Class II device.