FDA 510(k) Application Details - K041442

Device Classification Name	Generator, Pulse, Pacemaker, External Programmable   More FDA Info for this Device
510(K) Number	K041442
Device Name	Generator, Pulse, Pacemaker, External Programmable
Applicant	EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 RT. 73 NORTH, BLDG. D WEST BERLIN, NJ 08091 US Other 510(k) Applications for this Company
Contact	JAMES E KUHN JR. 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	06/01/2004
Decision Date	09/14/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review