Clearance Summary
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED received FDA 510(k) clearance under submission number K113699, sponsored by The Procter & Gamble Company. 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 2012-01-12.
- Submission: K113699
- Applicant / Sponsor: The Procter & Gamble Company
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2012-01-12
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.