Clearance Summary
ESPI REDUCER SLEEVE, #8415 received FDA 510(k) clearance under submission number K903596, sponsored by Dixon Medical, 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 1990-09-12.
- Submission: K903596
- Applicant / Sponsor: Dixon Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1990-09-12
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.