Clearance Summary
DIENER RETRIEVAL DEVICES received FDA 510(k) clearance under submission number K950559, sponsored by Mill-Rose Laboratory. 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 1995-02-16.
- Submission: K950559
- Applicant / Sponsor: Mill-Rose Laboratory
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1075
- Decision date: 1995-02-16
Classification & Regulation
This clearance is catalogued under FDA product code FCL and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class I device.