Clearance Summary
CMI VACUUM PUMP received FDA 510(k) clearance under submission number K914552, 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 1993-09-07.
- Submission: K914552
- Applicant / Sponsor: Columbia Medical & Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4400
- Decision date: 1993-09-07
Classification & Regulation
This clearance is catalogued under FDA product code HDA and 21 CFR 884.4400, within the Obstetrics/Gynecology review panel as a Class II device.