FDA 510(k) Application Details - K081997

Device Classification Name	System&Accessories,Isolated Heart,Transport&Preservation   More FDA Info for this Device
510(K) Number	K081997
Device Name	System&Accessories,Isolated Heart,Transport&Preservation
Applicant	VITROLIFE SWEDEN AB FAKTORVAGEN 13 KUNGSBACKA SE-434 37 SE Other 510(k) Applications for this Company
Contact	KJELL KJORK Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	MSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2008
Decision Date	10/09/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review