Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K022730
Device Classification Name
System&Accessories,Isolated Heart,Transport&Preservation
More FDA Info for this Device
510(K) Number
K022730
Device Name
System&Accessories,Isolated Heart,Transport&Preservation
Applicant
VITROLIFE 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
08/16/2002
Decision Date
10/27/2003
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact