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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 K053539
Device Name MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
Applicant
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact DAVID E CURTIN
Correspondent
BAXTER HEALTHCARE CORPORATION
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact DAVID E CURTIN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/20/2005
Decision Date 05/24/2006
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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