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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 K062079
Device Name XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
Applicant
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MPGR-AL
MCGAW PARK,  IL  60085
Applicant Contact DAVID E CURTIN
Correspondent
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MPGR-AL
MCGAW PARK,  IL  60085
Correspondent Contact DAVID E CURTIN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/21/2006
Decision Date 10/19/2006
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
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