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FDA 510(k) Application Details - K020924
Device Classification Name
Set, Perfusion, Kidney, Disposable
More FDA Info for this Device
510(K) Number
K020924
Device Name
Set, Perfusion, Kidney, Disposable
Applicant
DR. FRANZ KOHLER CHEMIE GMBH
2305 GOLD MINE RD.
BROOKEVILLE, MD 20833 US
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Contact
T. WHIT ATHEY
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
KDL
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More FDA Info for this Product Code
Date Received
03/21/2002
Decision Date
01/06/2003
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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