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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 K122361
Device Name T:CONNECT DATA MANAGEMENT SYSTEM
Original Applicant
TANDEM DIABETES CARE, INC.
11045 roselle st ste 200
san diego,  CA  92121
Original Contact don canal
Regulation Number880.5725
Classification Product Code
LZG  
Date Received08/03/2012
Decision Date 02/22/2013
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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