FDA 510(k) Application Details - K002687

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K002687
Device Name	Electrode, Pacemaker, Temporary
Applicant	ZYNERGY CARDIOVASCULAR, INC. 298 FERNWOOD AVE. EDISON, NJ 08837-3839 US Other 510(k) Applications for this Company
Contact	JING ZHANG Other 510(k) Applications for this Contact
Regulation Number	870.3680   More FDA Info for this Regulation Number
Classification Product Code	LDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2000
Decision Date	11/09/2000
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