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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 K011221
Device Name PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
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 Received04/20/2001
Decision Date 10/31/2001
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
Recalls CDRH Recalls
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