Clearance Summary
FEMININE HYGIENE DEVICE received FDA 510(k) clearance under submission number K831667, sponsored by Snow Willow Co.. 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 1983-09-12.
- Submission: K831667
- Applicant / Sponsor: Snow Willow Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5900
- Decision date: 1983-09-12
Classification & Regulation
This clearance is catalogued under FDA product code HED and 21 CFR 884.5900, within the Obstetrics/Gynecology review panel as a Class I device.