FDA 510(k) Application Details - K122611

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K122611
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	ATRICURE, INC. 6217 CENTRE PARK DRIVE WEST CHESTER, OH 45069 US Other 510(k) Applications for this Company
Contact	JIM LUCKY, RAC 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	08/27/2012
Decision Date	09/26/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review