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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 K063183
Device Name PRISMA M10 PRE SET
Applicant
Gambro Renal Products, Inc.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Gambro Renal Products, Inc.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/19/2006
Decision Date 02/15/2007
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
Predetermined Change
Control Plan Authorized		 No
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