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FDA 510(k) Application Details - K180481
Device Classification Name
System, Perfusion, Kidney
More FDA Info for this Device
510(K) Number
K180481
Device Name
System, Perfusion, Kidney
Applicant
S.A.L.F. spa
Via Marconi 2
Cenate Sotto 24069 IT
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Contact
Carmelo Gagliano
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
02/23/2018
Decision Date
06/29/2018
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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