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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 K945747
Device Name GAMBRO LUNDIA 94-600 DIALYZER
Applicant
Cobe Renal Care, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact JEFFREY R SHIEDMAN
Correspondent
Cobe Renal Care, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact JEFFREY R SHIEDMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/23/1994
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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