Clearance Summary
UNSCENTED MENSTRUAL PAD TIER-1 REVIEW received FDA 510(k) clearance under submission number K940377, sponsored by Eldari, Ltd.. 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 1994-03-25.
- Submission: K940377
- Applicant / Sponsor: Eldari, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1994-03-25
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.