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FDA 510(k) Application Details - K203234
Device Classification Name
More FDA Info for this Device
510(K) Number
K203234
Device Name
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Applicant
Tandem Diabetes Care, Inc.
11075 Roselle Street
San Diego, CA 92121 US
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Contact
Ashley Reynolds
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFG
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More FDA Info for this Product Code
Date Received
11/03/2020
Decision Date
02/15/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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