FDA 510(k) Application Details - K033858

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K033858
Device Name	Electrode, Pacemaker, Temporary
Applicant	EUROPEAN CUSTOM MANUFACTURING BV OOST-OM 54 NL-5422 VZ GEMERT NL Other 510(k) Applications for this Company
Contact	MAARTEN KANTERS 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	12/11/2003
Decision Date	07/12/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review