Clearance Summary
NAVARRE 600 ML DRAINAGE BAG received FDA 510(k) clearance under submission number K943663, sponsored by Navarre Biomedical , Ltd.. 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 1994-09-08.
- Submission: K943663
- Applicant / Sponsor: Navarre Biomedical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1994-09-08
Classification & Regulation
This clearance is catalogued under FDA product code EXF and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.