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510(k) K254102

Glucommander by Glytec, LLC — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
December 19, 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

Other clearances by Glytec, LLC

  • K152300 — Glucommander (August 4, 2017)
  • K113853 — G+ SYSTEM (May 8, 2012)

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