PRISMAFLEX SYSTEM 7.10

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 System 7.10.

Pre-market Notification Details

Device IDK131516
510k NumberK131516
Device Name:PRISMAFLEX SYSTEM 7.10
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 Received2013-05-28
Decision Date2014-01-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332414126766 K131516 000
07332414124236 K131516 000
07332414117702 K131516 000

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