Clearance Summary
CMI VELVET TOUCH VACUUM EXTRACTOR received FDA 510(k) clearance under submission number K942725, sponsored by Columbia Medical & Surgical, 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 1995-05-05.
- Submission: K942725
- Applicant / Sponsor: Columbia Medical & Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 1995-05-05
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.