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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 K062090
Device Name PRISMA SYSTEM R03.10A
Applicant
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact THOMAS B DOWELL
Correspondent
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact THOMAS B DOWELL
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/24/2006
Decision Date 10/18/2006
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
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