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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 K884609
Device Name EURO-COLLINS SOLUTION SETS
Applicant
Fresenius USA, Inc.
Verwaltung: Borkenberg 14
6370 Oberursel/Taunus 1
Germany,  DE
Applicant Contact ERIC HOLST
Correspondent
Fresenius USA, Inc.
Verwaltung: Borkenberg 14
6370 Oberursel/Taunus 1
Germany,  DE
Correspondent Contact ERIC HOLST
Regulation Number876.5880
Classification Product Code
KDL  
Date Received11/07/1988
Decision Date 01/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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