510(k) K111467

FLEXI-Q DV AND DVR AUTO-INJECTORS by Elcam Medical Acal — Product Code KZH

K111467 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "FLEXI-Q DV AND DVR AUTO-INJECTORS". The FDA issued a decision of Substantially Equivalent on February 9, 2012. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Elcam Medical Acal has at least 10 other 510(k) clearances on record.