FDA 510(k) Application Details - K011988

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K011988
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	CARDIOFOCUS, INC. 10 COMMERCE WAY NORTON, MA 02766 US Other 510(k) Applications for this Company
Contact	JOSEPH CURTIS 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	06/26/2001
Decision Date	09/20/2001
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