Clearance Summary
PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH received FDA 510(k) clearance under submission number K862098, sponsored by Hall/Mccollum Laboratories, 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 1986-11-12.
- Submission: K862098
- Applicant / Sponsor: Hall/Mccollum Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1986-11-12
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.