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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 K160056
Device Name t:slim Insulin Delivery System
Applicant
Tandem Diabetes Care, Inc.
11045 Roselle St.
San Diego,  CA  92121
Applicant Contact Michael Sarrasin
Correspondent
Tandem Diabetes Care, Inc.
11045 Roselle St.
San Diego,  CA  92121
Correspondent Contact Michael Sarrasin
Regulation Number880.5725
Classification Product Code
LZG  
Date Received01/12/2016
Decision Date 07/25/2016
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
Predetermined Change
Control Plan Authorized		 No
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