Clearance Summary
WHENEVER UNSCENTED PANTY SHIELD received FDA 510(k) clearance under submission number K861357, sponsored by Marcal Paper Mills, 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 1986-04-23.
- Submission: K861357
- Applicant / Sponsor: Marcal Paper Mills, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1986-04-23
Classification & Regulation
This clearance is catalogued under FDA product code HHD and 21 CFR 884.5435, within the Obstetrics/Gynecology review panel as a Class I device.