FDA 510(k) Application Details - K023174

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K023174
Device Name	Electrode, Pacemaker, Temporary
Applicant	RIVER MEDICAL, INC. 836 NE 24TH AVE. PORTLAND, OR 97232 US Other 510(k) Applications for this Company
Contact	MARY ANN GREENAWALT 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	09/23/2002
Decision Date	06/11/2003
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