FDA 510(k) Application Details - K000881

Device Classification Name	System&Accessories,Isolated Heart,Transport&Preservation   More FDA Info for this Device
510(K) Number	K000881
Device Name	System&Accessories,Isolated Heart,Transport&Preservation
Applicant	VITROLIFE SWEDEN AB 155 CIDER MILL RD. RINGOES, NJ 08551 US Other 510(k) Applications for this Company
Contact	KARL A POSSELT 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	03/20/2000
Decision Date	03/08/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review