Clearance Summary
DEVICE, FEMALE INCONTINENCE received FDA 510(k) clearance under submission number K781863, sponsored by Eschmann Bros. & Walsh , 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 1978-11-06.
- Submission: K781863
- Applicant / Sponsor: Eschmann Bros. & Walsh , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 1978-11-06
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.