Clearance Summary
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS received FDA 510(k) clearance under submission number K042773, 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 2004-11-23.
- Submission: K042773
- Applicant / Sponsor: Rostam , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 2004-11-23
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.