Clearance Summary
LA JOIE received FDA 510(k) clearance under submission number K000736, sponsored by Goomi Ehwa, 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 2000-08-08.
- Submission: K000736
- Applicant / Sponsor: Goomi Ehwa, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5900
- Decision date: 2000-08-08
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.