FDA 510(k) Application Details - K093858

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K093858
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. SYLMAR, CA 91342 US Other 510(k) Applications for this Company
Contact	Beena Flynn Other 510(k) Applications for this Contact
Regulation Number	870.2900   More FDA Info for this Regulation Number
Classification Product Code	DSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2009
Decision Date	04/02/2010
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