510(k) K093310

GEM FLOW COUPLER DEVICE AND SYSTEM by Synovis Micro Companies Alliance, Inc. — Product Code MVR

K093310 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance, Inc. for the device "GEM FLOW COUPLER DEVICE AND SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2010. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Synovis Micro Companies Alliance, Inc. has at least 4 other 510(k) clearances on record.