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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 K900918
Device Name GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
Applicant
Gambro, Inc.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Gambro, Inc.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/27/1990
Decision Date 07/16/1990
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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