Clearance Summary
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA received FDA 510(k) clearance under submission number K854258, 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 1985-11-21.
- Submission: K854258
- Applicant / Sponsor: Intl. Playtex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 1985-11-21
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.