T:flex 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:flex Insulin Delivery System.

Pre-market Notification Details

Device IDK143189
510k NumberK143189
Device Name:T:flex Insulin Delivery System
ClassificationPump, Infusion, Insulin
Applicant Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego,  CA  92121
ContactJohn Sheridan
CorrespondentJanice Hogan
Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia,  PA  19103
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-05
Decision Date2015-01-09
Summary:summary

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