PRISMA M60/M100 SETS

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Prisma M60/m100 Sets.

Pre-market Notification Details

Device IDK032431
510k NumberK032431
Device Name:PRISMA M60/M100 SETS
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant GAMBRO, INC. 10810 W. COLLINS AVE. Lakewood,  CO  80215
ContactRod J Rylands
CorrespondentRod J Rylands
GAMBRO, INC. 10810 W. COLLINS AVE. Lakewood,  CO  80215
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-06
Decision Date2003-09-15
Summary:summary

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