T:slim Insulin Delivery System

Pump, Infusion, Insulin

Tandem Diabetes Care, Inc.

The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for T:slim Insulin Delivery System.

Pre-market Notification Details

Device IDK160056
510k NumberK160056
Device Name:T:slim Insulin Delivery System
ClassificationPump, Infusion, Insulin
Applicant Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego,  CA  92121
ContactMichael Sarrasin
CorrespondentMichael Sarrasin
Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego,  CA  92121
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-12
Decision Date2016-07-25
Summary:summary

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