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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 K103564
Device Name VENOFER PUMP
Applicant
Renal Solutions, Inc.
770 Commonwealth Dr. Suite 101
Warrendale,  PA  15086
Applicant Contact DAVID VANELLA
Correspondent
Renal Solutions, Inc.
770 Commonwealth Dr. Suite 101
Warrendale,  PA  15086
Correspondent Contact DAVID VANELLA
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/06/2010
Decision Date 02/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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