Clearance Summary
CUMEVAC received FDA 510(k) clearance under submission number K874410, sponsored by Cumes-Honikman Partnership. 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 1987-12-03.
- Submission: K874410
- Applicant / Sponsor: Cumes-Honikman Partnership
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4370
- Decision date: 1987-12-03
Classification & Regulation
This clearance is catalogued under FDA product code FFD and 21 CFR 876.4370, within the Gastroenterology, Urology review panel as a Class I device.