FDA 510(k) Application Details - K100501

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K100501
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	ATRICURE, INC. 6217 CENTER PARK DRIVE WEST CHESTER, OH 45069 US Other 510(k) Applications for this Company
Contact	JAMES LUCKY 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	02/22/2010
Decision Date	06/18/2010
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