RENAGUARD DIALYSATE FILTER

Subsystem, Water Purification

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaguard Dialysate Filter.

Pre-market Notification Details

Device IDK945136
510k NumberK945136
Device Name:RENAGUARD DIALYSATE FILTER
ClassificationSubsystem, Water Purification
Applicant MINNTECH CORP. 14905 28TH AVE. N. Minneapolis,  MN  55447
ContactLeroy J Fischbach
CorrespondentLeroy J Fischbach
MINNTECH CORP. 14905 28TH AVE. N. Minneapolis,  MN  55447
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-20
Decision Date1995-02-28

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