FIK — System, Dialysate Delivery, Recirculating Class II

FDA Device Classification

FDA product code FIK covers "System, Dialysate Delivery, Recirculating", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
FIK
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No