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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, perfusion, kidney, disposable
510(k) Number K020924
Device Name CUSTODIOL HTK SOLUTION
Applicant
DR. FRANZ KOHLER CHEMIE GMBH
2305 GOLD MINE RD.
BROOKEVILLE,  MD  20833
Applicant Contact T. WHIT ATHEY
Correspondent
DR. FRANZ KOHLER CHEMIE GMBH
2305 GOLD MINE RD.
BROOKEVILLE,  MD  20833
Correspondent Contact T. WHIT ATHEY
Regulation Number876.5880
Classification Product Code
KDL  
Date Received03/21/2002
Decision Date 01/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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