510(k) K171952

Dimesol Tubing Sets for Hemodialysis by Dimesol, Inc. — Product Code FJK

K171952 is an FDA 510(k) premarket notification submitted by Dimesol, Inc. for the device "Dimesol Tubing Sets for Hemodialysis". The FDA issued a decision of Substantially Equivalent on March 30, 2018. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Dimesol, Inc. has at least 1 other 510(k) clearance on record.