RENACLEAR DIALYZER CLEANING SYSTEM

Dialyzer Reprocessing System

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaclear Dialyzer Cleaning System.

Pre-market Notification Details

Device IDK991851
510k NumberK991851
Device Name:RENACLEAR DIALYZER CLEANING SYSTEM
ClassificationDialyzer Reprocessing System
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactRichard M Ormsbee
CorrespondentRichard M Ormsbee
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 Received1999-06-01
Decision Date1999-08-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.