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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 K010805
Device Name PRISMA SYSTEM
Applicant
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact SUZANNE DENNIS
Correspondent
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact SUZANNE DENNIS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/16/2001
Decision Date 08/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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