510(k) K141254

ELCAM STOPCOCKS AND MANIFOLDS by Elcam Medical Acal — Product Code FMG

K141254 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "ELCAM STOPCOCKS AND MANIFOLDS". The FDA issued a decision of Substantially Equivalent on July 30, 2014. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Elcam Medical Acal has at least 10 other 510(k) clearances on record.