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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 K960474
Device Name COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
Applicant
Cobe Renal Care, Inc.
1185 Oak St.
Lakewood,  CO  80215 -4407
Applicant Contact JEFFREY R SHIDERMAN
Correspondent
Cobe Renal Care, Inc.
1185 Oak St.
Lakewood,  CO  80215 -4407
Correspondent Contact JEFFREY R SHIDERMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/02/1996
Decision Date 08/14/1996
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
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