PRISMAFLEX M150 SET

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 Prismaflex M150 Set.

Pre-market Notification Details

Device IDK080519
510k NumberK080519
Device Name:PRISMAFLEX M150 SET
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 Received2008-02-25
Decision Date2008-06-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414090006 K080519 000

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