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510(k) K152300

Glucommander by Glytec, LLC — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2017
Date Received
August 14, 2015
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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