Clearance Summary
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS received FDA 510(k) clearance under submission number K132819, sponsored by Playtex Manufacturing, Inc.. 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 2013-10-09.
- Submission: K132819
- Applicant / Sponsor: Playtex Manufacturing, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 2013-10-09
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.