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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 K111210
Device Name T:SLIM (TM) INSULIN DELIVERY SYSTEM
Applicant
TANDEM DIABETES CARE, INC.
11045 ROSELLE STREET
SUITE 200
SAN DIEGO,  CA  92121
Applicant Contact DON CANAL
Correspondent
TANDEM DIABETES CARE, INC.
11045 ROSELLE STREET
SUITE 200
SAN DIEGO,  CA  92121
Correspondent Contact DON CANAL
Regulation Number880.5725
Classification Product Code
LZG  
Date Received04/29/2011
Decision Date 11/09/2011
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
Recalls CDRH Recalls
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