510(k) K060231

CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK by Elcam Medical Acal — Product Code FMG

K060231 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK". The FDA issued a decision of Substantially Equivalent on April 13, 2006. 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.