Clearance Summary
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED received FDA 510(k) clearance under submission number K131543, sponsored by Procter & Gamble Co.. 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 2013-06-20.
- Submission: K131543
- Applicant / Sponsor: Procter & Gamble Co.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2013-06-20
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.