TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

Tank, Holding, Dialysis

TANGO3, LLC

The following data is part of a premarket notification filed by Tango3, Llc with the FDA for Tango3 Water Storage Tank With Ozone Disinfection System.

Pre-market Notification Details

Device IDK140984
510k NumberK140984
Device Name:TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
ClassificationTank, Holding, Dialysis
Applicant TANGO3, LLC 141 CITIZENS BLVD Simpsonville,  KY  40067
ContactLori Holder
CorrespondentLori Holder
TANGO3, LLC 141 CITIZENS BLVD Simpsonville,  KY  40067
Product CodeFIN  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-16
Decision Date2015-01-12
Summary:summary

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