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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 K041005
Device Name GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
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 Received04/19/2004
Decision Date 10/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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