Clearance Summary
GELLHORN PESSARY 33410 VARIOUS SIZES received FDA 510(k) clearance under submission number K890565, sponsored by Medi-Source, 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 1989-03-29.
- Submission: K890565
- Applicant / Sponsor: Medi-Source, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 1989-03-29
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.