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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 K831784
Device Name HEMOFILTRATION SYSTEM
Applicant
Gambro, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gambro, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5860
Classification Product Code
KDI  
Date Received06/02/1983
Decision Date 02/04/1984
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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