510(k) K911813

ENTREE CANNULA by Core Dynamics, Inc. — Product Code FBM

K911813 is an FDA 510(k) premarket notification submitted by Core Dynamics, Inc. for the device "ENTREE CANNULA". The FDA issued a decision of Substantially Equivalent on July 19, 1991. The device falls under product code FBM (Cannula And Trocar, Suprapubic, Non-Disposable), a Class I device regulated under 21 CFR 876.5090. Core Dynamics, Inc. has at least 10 other 510(k) clearances on record.