ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM

Subsystem, Water Purification

FLIER'S QUALITY WATER SYSTEMS INC

The following data is part of a premarket notification filed by Flier's Quality Water Systems Inc with the FDA for Acute Portable Exchange Deionization (pedi) System, Central Pedi System, Back-up Pedi System.

Pre-market Notification Details

Device IDK071104
510k NumberK071104
Device Name:ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
ClassificationSubsystem, Water Purification
Applicant FLIER'S QUALITY WATER SYSTEMS INC 7425 CLYDE PARK AVENUE SW SUITE A Byron Center,  MI  49315
ContactJames Flier
CorrespondentJames Flier
FLIER'S QUALITY WATER SYSTEMS INC 7425 CLYDE PARK AVENUE SW SUITE A Byron Center,  MI  49315
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-19
Decision Date2008-01-14
Summary:summary

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