FDA 510(k) Application Details - K172721

Device Classification Name	More FDA Info for this Device
510(K) Number	K172721
Device Name	FOCAL ONE
Applicant	EDAP Technomed, Inc. 5321 Industrial Oaks Blvd, Suite 110 AUSTIN, TX 78735 US Other 510(k) Applications for this Company
Contact	Hugo Embert Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2017
Decision Date	06/07/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review