FDA 510(k) Application Details - K955829

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K955829
Device Name	Electrode, Pacemaker, Temporary
Applicant	B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. BETHLEHEM, PA 18018 US Other 510(k) Applications for this Company
Contact	MARK S ALSBERGE 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	12/26/1995
Decision Date	11/18/1997
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