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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 K133593
FOIA Releasable 510(k) K133593
Device Name T:SLIM INSULIN DELIVERY SYSTEM
Applicant
TANDEM DIABETES CARE, INC.
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JOHN SHERIDAN
Correspondent
TANDEM DIABETES CARE, INC.
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JOHN SHERIDAN
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/22/2013
Decision Date 03/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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