RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330

Dialyzer Reprocessing System

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renatron Ii Dialyzer Reprocessing System Rs 8330.

Pre-market Notification Details

Device IDK904210
510k NumberK904210
Device Name:RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
ClassificationDialyzer Reprocessing System
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactLeroy Fischbach
CorrespondentLeroy Fischbach
MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
Product CodeLIF  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-12
Decision Date1990-11-27

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