510(k) K100704

ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE by Disetronic Medical Systems AG — Product Code FRN

K100704 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE". The FDA issued a decision of Substantially Equivalent on May 14, 2010. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.