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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 K970253
Device Name COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
Applicant
Gambro Healthcare
1185 Oak St.
Lakewood,  CO  80215 -4498
Applicant Contact BENITA BOURQUE,, RAC
Correspondent
Gambro Healthcare
1185 Oak St.
Lakewood,  CO  80215 -4498
Correspondent Contact BENITA BOURQUE,, RAC
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/22/1997
Decision Date 09/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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