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FKE — Tie, Dialysis Class I

FDA Device Classification

FDA product code FKE covers "Tie, Dialysis", a Class I medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code: FKE
Device Class: Class I
Regulation Number: 876.5820
Submission Type
Review Panel: GU
Medical Specialty: Gastroenterology, Urology
Implant: No