510(k) K990034

WILSON-COOK COLONIC Z-STENT by Med Institute, Inc. — Product Code MQR

K990034 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "WILSON-COOK COLONIC Z-STENT". The FDA issued a decision of Substantially Equivalent on April 17, 2000. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. Med Institute, Inc. has at least 10 other 510(k) clearances on record.