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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 K961465
Device Name 2008H ON LINE CLEARANCE MONITOR
Applicant
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Applicant Contact TOM FOLDEN
Correspondent
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Correspondent Contact TOM FOLDEN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/17/1996
Decision Date 07/03/1997
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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