UPT Series Medical RO Water System

Subsystem, Water Purification

Specialty Water Technologies

The following data is part of a premarket notification filed by Specialty Water Technologies with the FDA for Upt Series Medical Ro Water System.

Pre-market Notification Details

Device IDK151637
510k NumberK151637
Device Name:UPT Series Medical RO Water System
ClassificationSubsystem, Water Purification
Applicant Specialty Water Technologies 1020 Industrial Drive Orlinda,  TN  37141
ContactAlex Clark
CorrespondentAlex Clark
Specialty Water Technologies 1020 Industrial Drive Orlinda,  TN  37141
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-17
Decision Date2015-09-23
Summary:summary

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