Custodiol HTK Solution

Set, Perfusion, Kidney, Disposable

Dr. Franz Kohler Chemie GmbH

The following data is part of a premarket notification filed by Dr. Franz Kohler Chemie Gmbh with the FDA for Custodiol Htk Solution.

Pre-market Notification Details

Device IDK192408
510k NumberK192408
Device Name:Custodiol HTK Solution
ClassificationSet, Perfusion, Kidney, Disposable
Applicant Dr. Franz Kohler Chemie GmbH Werner-von-Siemens-Strabe 14-28 Bensheim,  DE 64625
ContactClifton Czarnojon
CorrespondentClifton Czarnojon
Dr. Franz Kohler Chemie GmbH Werner-von-Siemens-Strabe 14-28 Bensheim,  DE 64625
Product CodeKDL  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-04
Decision Date2020-04-24

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