FDA 510(k) Application Details - K200061

Device Classification Name	System, Ablation, Microwave And Accessories   More FDA Info for this Device
510(K) Number	K200061
Device Name	System, Ablation, Microwave And Accessories
Applicant	Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 US Other 510(k) Applications for this Company
Contact	Amy Mckinney 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	01/13/2020
Decision Date	07/09/2020
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