PHOENIX HEMODIALYSIS DELIVERY SYSTEM

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO RENAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Phoenix Hemodialysis Delivery System.

Pre-market Notification Details

Device IDK103832
510k NumberK103832
Device Name:PHOENIX HEMODIALYSIS DELIVERY SYSTEM
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood,  CO  80401
ContactKae Miller
CorrespondentKae Miller
GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood,  CO  80401
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-30
Decision Date2011-05-20
Summary:summary

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