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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
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