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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K123288
Device Name HEMOCONCENTRATOR
Applicant
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Applicant Contact INGRID RICHTER
Correspondent
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Correspondent Contact INGRID RICHTER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/22/2012
Decision Date 06/26/2013
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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