CUSTODIOL

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.

Pre-market Notification Details

Device IDK043461
510k NumberK043461
Device Name:CUSTODIOL
ClassificationSet, Perfusion, Kidney, Disposable
Applicant DR. FRANZ KOHLER CHEMIE GMBH 2305 GOLD MINE RD. Brookeville,  MD  20833
ContactT. Whit Athey
CorrespondentT. Whit Athey
DR. FRANZ KOHLER CHEMIE GMBH 2305 GOLD MINE RD. Brookeville,  MD  20833
Product CodeKDL  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-15
Decision Date2005-02-28
Summary:summary

Trademark Results [CUSTODIOL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CUSTODIOL
CUSTODIOL
75093836 2221916 Live/Registered
Dr. Franz Kohler Chemie GmbH
1996-04-25

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