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510(k) K252104

T1D1 by Comerge AG — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2025
Date Received
July 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

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