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FDA 510(k) Application Details - K223874
Device Classification Name
System, Perfusion, Kidney
More FDA Info for this Device
510(K) Number
K223874
Device Name
System, Perfusion, Kidney
Applicant
Paragonix Technologies
Suite 408, 639 Granite St.
Braintree, MA 02184 US
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Contact
Nathan Yetton
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
12/23/2022
Decision Date
08/15/2023
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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