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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 K963440
Device Name DIALOG DIALYSIS MACHINE
Applicant
B. Braun Medical AG
824 12th Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun Medical AG
824 12th Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/30/1996
Decision Date 06/26/1998
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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