VENOFER PUMP

Dialyzer, High Permeability With Or Without Sealed Dialysate System

RENAL SOLUTIONS INC.

The following data is part of a premarket notification filed by Renal Solutions Inc. with the FDA for Venofer Pump.

Pre-market Notification Details

Device IDK093964
510k NumberK093964
Device Name:VENOFER PUMP
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant RENAL SOLUTIONS INC. 770 COMMONWEALTH DRIVE SUITE 101 Warrendale,  PA  15086
ContactDavid Vanella
CorrespondentDavid Vanella
RENAL SOLUTIONS INC. 770 COMMONWEALTH DRIVE SUITE 101 Warrendale,  PA  15086
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-24
Decision Date2010-07-09
Summary:summary

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