Clearance Summary
HAYES VAGINAL SHIELD received FDA 510(k) clearance under submission number K862478, sponsored by Franklin Medical USA, 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 1986-11-24.
- Submission: K862478
- Applicant / Sponsor: Franklin Medical USA, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1986-11-24
Classification & Regulation
This clearance is catalogued under FDA product code HDF and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.