Clearance Summary
CLAMP, TUBING, LINE received FDA 510(k) clearance under submission number K844121, sponsored by Dyn-A-Med Products. 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 1984-12-17.
- Submission: K844121
- Applicant / Sponsor: Dyn-A-Med Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1984-12-17
Classification & Regulation
This clearance is catalogued under FDA product code FKK and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.