Clearance Summary
MODIFICATION TO PLAYTEX TAMPONS #24002 received FDA 510(k) clearance under submission number K022882, sponsored by Playtex Products, 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 2002-09-16.
- Submission: K022882
- Applicant / Sponsor: Playtex Products, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 2002-09-16
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.