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FDA 510(k) Application Details - K122361
Device Classification Name
More FDA Info for this Device
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 US
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Contact
DON CANAL
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2012
Decision Date
02/22/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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