Clearance Summary
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER received FDA 510(k) clearance under submission number K881057, sponsored by 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 1988-03-22.
- Submission: K881057
- Applicant / Sponsor: Playtex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 1988-03-22
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.