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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name medical device data system
510(k) Number K122361
Device Name T:CONNECT DATA MANAGEMENT SYSTEM
Applicant
TANDEM DIABETES CARE, INC.
11045 Roselle St Ste 200
San Diego,  CA  92121
Applicant Contact DON CANAL
Correspondent
TANDEM DIABETES CARE, INC.
11045 Roselle St Ste 200
San Diego,  CA  92121
Correspondent Contact DON CANAL
Regulation Number880.6310
Classification Product Code
OUG  
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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