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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, central multiple patient
510(k) Number K052764
Device Name DIACAP ULTRA DIALYSIS FLUID FILTER
Applicant
B. BRAUN MEDIZINTECHNOLOGIE GMBH
SCHWARZENBERGER WEG 73-79
MELSUNGEN,  DE D-34212
Applicant Contact SCOTT J PEASE
Correspondent
B. BRAUN MEDIZINTECHNOLOGIE GMBH
SCHWARZENBERGER WEG 73-79
MELSUNGEN,  DE D-34212
Correspondent Contact SCOTT J PEASE
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received09/30/2005
Decision Date 06/09/2006
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
Recalls CDRH Recalls
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