FDA 510(k) Application Details - K113475

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K113475
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 SAN RAMON, CA 94583 US Other 510(k) Applications for this Company
Contact	TAMER IBRAHIM Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	OCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2011
Decision Date	03/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review