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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name alternate controller enabled insulin infusion pump
De Novo Number DEN180058
Device Name t:slim X2 insulin pump with interoperable technology
Requester
Tandem Diabetes Care, Inc.
11075 roselle street
san diego,  CA  92121
Contact michael sarrasin
Regulation Number880.5730
Classification Product Code
QFG  
Date Received10/29/2018
Decision Date 02/14/2019
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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