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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 K083778
Device Name XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
Applicant
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact DIANE RENNPFERD
Correspondent
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact DIANE RENNPFERD
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/19/2008
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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