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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 K974652
Device Name BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact DAVID E CURTIN
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact DAVID E CURTIN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/12/1997
Decision Date 07/10/1998
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
Recalls CDRH Recalls
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