510(k) K032393

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) by Elcam Medical Acal — Product Code FMG

K032393 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)". The FDA issued a decision of Substantially Equivalent on September 12, 2003. 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.