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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 K083460
FOIA Releasable 510(k) K083460
Device Name DIALOG WITH ADIMEA OPTION
Applicant
B. Braun Avitum AG
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact BONNIE KINCAID, RAC
Correspondent
B. Braun Avitum AG
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact BONNIE KINCAID, RAC
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/21/2008
Decision Date 02/18/2010
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
Recalls CDRH Recalls
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