GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

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 Gambro Polyflux Hemodialyzer, Model: Hd-c4 Small.

Pre-market Notification Details

Device IDK072232
510k NumberK072232
Device Name:GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-10
Decision Date2007-09-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414101696 K072232 000

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