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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion, insulin
510(k) Number K143189
Device Name t:flex Insulin Delivery System
Applicant
Tandem Diabetes Care, Inc.
11045 Roselle Street
San Diego,  CA  92121
Applicant Contact John Sheridan
Correspondent
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/05/2014
Decision Date 01/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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