FDA 510(k) Application Details - K163118

Device Classification Name	System, Ablation, Microwave And Accessories   More FDA Info for this Device
510(K) Number	K163118
Device Name	System, Ablation, Microwave And Accessories
Applicant	NEUWAVE MEDICAL, INC. 3529 ANDERSON STREET MADISON, WI 53704 US Other 510(k) Applications for this Company
Contact	DAN KOSEDNAR Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2016
Decision Date	03/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review