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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K072760
Device Name SOLCART B
Applicant
B. Braun Medizintechnologie GmbH
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact TRACY MADDOCK
Correspondent
B. Braun Medizintechnologie GmbH
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact TRACY MADDOCK
Regulation Number876.5820
Classification Product Code
KPO  
Date Received09/28/2007
Decision Date 01/29/2008
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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