RMI HEMOCONCENTRATOR

Dialyzer, High Permeability With Or Without Sealed Dialysate System

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Hemoconcentrator.

Pre-market Notification Details

Device IDK951344
510k NumberK951344
Device Name:RMI HEMOCONCENTRATOR
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale,  UT  84047
ContactRd Hibbert
CorrespondentRd Hibbert
RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale,  UT  84047
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-24
Decision Date1995-08-15

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