Clearance Summary
PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS received FDA 510(k) clearance under submission number K851355, sponsored by Intl. Playtex, Inc.. 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 1985-04-12.
- Submission: K851355
- Applicant / Sponsor: Intl. Playtex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 1985-04-12
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.