CUSTODIOL

System And Accessories, Isolated Heart, Transport And Preservation

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 IDK032794
510k NumberK032794
Device Name:CUSTODIOL
ClassificationSystem And Accessories, Isolated Heart, Transport And Preservation
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 CodeMSB  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-08
Decision Date2004-04-05
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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