GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO RENAL PRODUCTS

The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Polyflux Hemodialyzer, Model 6h.

Pre-market Notification Details

Device IDK051520
510k NumberK051520
Device Name:GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood,  CO  80215
ContactThomas B Dowell
CorrespondentThomas B Dowell
GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood,  CO  80215
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-08
Decision Date2005-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414036387 K051520 000

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