FDA 510(k) Application Details - K142084

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K142084
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	NCONTACT SURGICAL, INC. 1001AVIATION PARKWAY, SUITE 400 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	JANE RICUPERO 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	07/31/2014
Decision Date	10/28/2014
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