FDA 510(k) Application Details - K070743

Device Classification Name	Generator, Pulse, Pacemaker, External Programmable   More FDA Info for this Device
510(K) Number	K070743
Device Name	Generator, Pulse, Pacemaker, External Programmable
Applicant	ST CARDIO TECHNOLOGIES, LLC 3901 TROON CIRCLE BROOMFIELD, CO 80020 US Other 510(k) Applications for this Company
Contact	BILL ABBOUD Other 510(k) Applications for this Contact
Regulation Number	870.1750   More FDA Info for this Regulation Number
Classification Product Code	JOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2007
Decision Date	07/02/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review