Clearance Summary
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS received FDA 510(k) clearance under submission number K891297, sponsored by Playtex Family Products, 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 1989-06-08.
- Submission: K891297
- Applicant / Sponsor: Playtex Family Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 1989-06-08
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.