510(k) K083537

MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM by Medwaves Incorporated — Product Code NEY

K083537 is an FDA 510(k) premarket notification submitted by Medwaves Incorporated for the device "MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 15, 2009. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Medwaves Incorporated has 2 other 510(k) clearances on record.