FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS

Subsystem, Water Purification

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Fiberflo Hollow Fiber Cartridge Water Filters.

Pre-market Notification Details

Device IDK954349
510k NumberK954349
Device Name:FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
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 Received1995-09-18
Decision Date1995-12-15

NIH GUDID Devices

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