Matrix Pre-Treatment Controller

Subsystem, Water Purification

BETTER WATER, LLC.

The following data is part of a premarket notification filed by Better Water, Llc. with the FDA for Matrix Pre-treatment Controller.

Pre-market Notification Details

Device IDK161844
510k NumberK161844
Device Name:Matrix Pre-Treatment Controller
ClassificationSubsystem, Water Purification
Applicant BETTER WATER, LLC. 698 SWAN DR. Smyrna,  TN  37167
ContactMike Cline
CorrespondentMike Cline
BETTER WATER, LLC. 698 SWAN DR. Smyrna,  TN  37167
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-05
Decision Date2016-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
PR0014 K161844 000
PR0013 K161844 000
PR0012 K161844 000
PR0011 K161844 000

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