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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 K030099
Device Name BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK,  IL  60085 -6730
Applicant Contact ROBERT L WILKINSON
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/10/2003
Decision Date 06/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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