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FDA 510(k) Application Details - K192408
Device Classification Name
Set, Perfusion, Kidney, Disposable
More FDA Info for this Device
510(K) Number
K192408
Device Name
Set, Perfusion, Kidney, Disposable
Applicant
Dr. Franz Kohler Chemie GmbH
Werner-von-Siemens-Strabe 14-28
Bensheim 64625 DE
Other 510(k) Applications for this Company
Contact
Clifton Czarnojon
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
KDL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2019
Decision Date
04/24/2020
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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