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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 K043461
Device Name CUSTODIOL
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  
Subsequent Product Code
MSB  
Date Received12/15/2004
Decision Date 02/28/2005
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
Predetermined Change
Control Plan Authorized		 No
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