Clearance Summary
CMI E-Z FLO BULB P.N. 701 received FDA 510(k) clearance under submission number K932128, sponsored by Columbia Medical & Surgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1994-04-07.
- Submission: K932128
- Applicant / Sponsor: Columbia Medical & Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-04-07
Classification & Regulation
This clearance is catalogued under FDA product code FFY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.