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FDA 510(k) Application Details - K073693
Device Classification Name
System, Perfusion, Kidney
More FDA Info for this Device
510(K) Number
K073693
Device Name
System, Perfusion, Kidney
Applicant
PRESERVATION SOLUTIONS, INC.
4250 GROVE STREET
DENVER, CO 80211 US
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Contact
NEIL BURRIS
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
KDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2007
Decision Date
07/03/2008
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
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