DIMI RRT System

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Dialco Medical Inc.

The following data is part of a premarket notification filed by Dialco Medical Inc. with the FDA for Dimi Rrt System.

Pre-market Notification Details

Device IDK193005
510k NumberK193005
Device Name:DIMI RRT System
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Dialco Medical Inc. 135 The West Mall, Unit 2 Toronto,  CA M9c1c2
ContactDanijela Domljanovic
CorrespondentDanijela Domljanovic
Dialco Medical Inc. 135 The West Mall, Unit 2 Toronto,  CA M9c1c2
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-28
Decision Date2020-08-28

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