FDA 510(k) Application Details - K153023

Device Classification Name	More FDA Info for this Device
510(K) Number	K153023
Device Name	Ablatherm Integrated Imaging
Applicant	EDAP TECHNOMED, INC. 2201 DENTON DR., SUITE 110 AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	MARC OCZACHOWSKI 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	10/15/2015
Decision Date	11/06/2015
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